- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00279201
The DURABLE Trial: Evaluating the Durability of Starter Insulin Regimens in Patients With Type 2 Diabetes (IOOV) (IOOV)
The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control
This study will compare insulin lispro low mixture [LM] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.
This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.
The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1188AAF
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Mar Del Plata, Argentina, 7600
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Pilar, Argentina, B1629ODT
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New South Wales
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Kingswood Penrith, New South Wales, Australia, 2747
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
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Keswick, South Australia, Australia, 5035
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Tasmania
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Burnie, Tasmania, Australia, 7320
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Victoria
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Box Hill, Victoria, Australia, 3128
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Western Australia
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Nedlands, Western Australia, Australia, 6009
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Curitiba, Brazil, 80060-900
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Porto Alegre, Brazil, 90035170
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Setor Oeste/Goiania, Brazil, 74043-110
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São Paulo, Brazil, 01221-020
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Alberta
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Calgary, Alberta, Canada, T3B 0M3
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Red Deer, Alberta, Canada, T4N 6V7
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
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New Brunswick
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Petitcodiac, New Brunswick, Canada, E4Z 4R6
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Ontario
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Ajax, Ontario, Canada, L1S 7K8
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Mississauga, Ontario, Canada, L5M 2V8
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Niagara Falls, Ontario, Canada, L2G 5X7
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Quebec
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Laval, Quebec, Canada, H7T 2P5
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Sherbrooke, Quebec, Canada, J1G 5K2
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Athens, Greece, 11526
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Nikaias - Piraeus, Greece, 18454
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Thessaloniki, Greece, 56429
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Eger, Hungary, 3300
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Pecs, Hungary, 7623
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Szekszard, Hungary, 7100
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Szentes, Hungary, 6600
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Ahemdabad, India, 380013
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Aligarh, India, 202002
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Bangalore, India, 560 054
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Coimbatore, India
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Hyderabaad, India, 500033
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Karnal/Haryana, India, 132 001
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Trivandrum, India, 695029
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Amsterdam, Netherlands, 1105 AZ
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Brunssum, Netherlands, 6442 BE
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Emmen, Netherlands, 7824 AA
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Hoogeveen, Netherlands, 7909 AA
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Nijmegen, Netherlands, 6500 HB
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Venlo, Netherlands, 5912 BL
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Zwijndrecht, Netherlands, 3331 LZ
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Bayamon, Puerto Rico, 00959
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Carolina, Puerto Rico, 00983
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Orcorvis, Puerto Rico, 00720
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Ponce, Puerto Rico, 00717-2075
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Rio Piedras, Puerto Rico, 00936
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San Juan, Puerto Rico, 00926
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Brasov, Romania, 500326
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Bucharest, Romania, 70266
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Cluj-Napoca, Romania, 3400
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Targu-Mures, Romania, 540136
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Timisoara, Romania, 1900
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Alcira, Spain, 46600
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Dos Hermanas, Spain, 41014
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Madrid, Spain, 28040
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Malaga, Spain, 29010
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Mosteles, Spain, 28935
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Requena, Spain, 46340
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Santander, Spain, 39008
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Alabama
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Mobile, Alabama, United States, 36617
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Arizona
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Litchfield Park, Arizona, United States, 85340
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Arkansas
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Little Rock, Arkansas, United States, 72205
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California
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Anaheim, California, United States, 92805
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Beverly Hills, California, United States, 90211
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Burlingame, California, United States, 94010
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Concord, California, United States, 94520
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Fountain Valley, California, United States, 92708
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Fresno, California, United States, 93720
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Greenbrae, California, United States, 94904
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La Jolla, California, United States, 92093
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La Mesa, California, United States, 91942
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Los Alamitos, California, United States, 90720
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Los Angeles, California, United States, 90095
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Los Gatos, California, United States, 95032
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Norwalk, California, United States, 90650
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Orange, California, United States, 92868
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Palm Springs, California, United States, 92262
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Sacramento, California, United States, 95825
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Salinas, California, United States, 93901
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San Diego, California, United States, 92161
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Spring Valley, California, United States, 91978
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Vacaville, California, United States, 95687
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Ventura, California, United States, 93003
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Colorado
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Colorado Springs, Colorado, United States, 80917
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Connecticut
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Cromwell, Connecticut, United States, 06416
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Trumbull, Connecticut, United States, 06611
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Waterbury, Connecticut, United States, 06708
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Florida
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Deerfield Beach, Florida, United States, 33441
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Gainesville, Florida, United States, 32605
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Inverness, Florida, United States, 34452
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Jacksonville, Florida, United States, 32208
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Kissimmee, Florida, United States, 34741
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Lake Worth, Florida, United States, 33461
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Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33125
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New Port Richey, Florida, United States, 34655
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Ocala, Florida, United States, 34471
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Tampa, Florida, United States, 33603
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West Palm Beach, Florida, United States, 33401
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Winter Park, Florida, United States, 32789
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Georgia
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Athens, Georgia, United States, 30606
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Atlanta, Georgia, United States, 30342
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Hawaii
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Honolulu, Hawaii, United States, 96814
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Idaho
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Kellogg, Idaho, United States, 83837
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Illinois
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Belleville, Illinois, United States, 62220
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Chicago, Illinois, United States, 60612
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Gurnee, Illinois, United States, 60031
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O'Fallon, Illinois, United States, 62269
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Peoria, Illinois, United States, 61615
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Indiana
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Fort Wayne, Indiana, United States, 46804
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Indianapolis, Indiana, United States, 46256
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Iowa
-
Waterloo, Iowa, United States, 50702
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Kansas
-
Topeka, Kansas, United States, 66606
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Kentucky
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Bowling Green, Kentucky, United States, 42101
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Madisonville, Kentucky, United States, 42431
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Owensboro, Kentucky, United States, 42303
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Louisiana
-
Baton Rouge, Louisiana, United States, 70808
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Metairie, Louisiana, United States, 70006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maine
-
Bangor, Maine, United States, 04401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Maryland
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Baltimore, Maryland, United States, 21204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Elkridge, Maryland, United States, 21075
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Elkton, Maryland, United States, 21921
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Reisterstown, Maryland, United States, 21136
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rockville, Maryland, United States, 20852
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Towson, Maryland, United States, 21204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Massachusetts
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Haverhill, Massachusetts, United States, 01830
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Waltham, Massachusetts, United States, 02453
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Worcester, Massachusetts, United States, 01605
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Bloomfield Hills, Michigan, United States, 48302
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Troy, Michigan, United States, 48098
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Minnesota
-
Bloomington, Minnesota, United States, 55420
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Chesterfield, Missouri, United States, 63017
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
St Louis, Missouri, United States, 63104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Las Vegas, Nevada, United States, 89148
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Reno, Nevada, United States, 89509
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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New Hampshire
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Nashua, New Hampshire, United States, 03063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
-
Cherry Hill, New Jersey, United States, 08034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Flemington, New Jersey, United States, 08822
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Hamilton, New Jersey, United States, 08610
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Stratford, New Jersey, United States, 08084
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Teaneck, New Jersey, United States, 07666
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Toms River, New Jersey, United States, 08753
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
-
Cooperstown, New York, United States, 13326
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Mamaroneck, New York, United States, 10543
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Massapequa, New York, United States, 11758
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
New Hartford, New York, United States, 13413
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
New York, New York, United States, 10032
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Syracuse, New York, United States, 13210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Westfield, New York, United States, 14787
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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North Carolina
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Charlotte, North Carolina, United States, 28226
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Greenville, North Carolina, United States, 27834
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Huntersville, North Carolina, United States, 28078
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Morehead City, North Carolina, United States, 28557
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Morganton, North Carolina, United States, 28655
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tabor City, North Carolina, United States, 28463
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Dakota
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Fargo, North Dakota, United States, 58104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Jamestown, North Dakota, United States, 58401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Ohio
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Akron, Ohio, United States, 44313
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Cincinnati, Ohio, United States, 45224
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Cleveland, Ohio, United States, 44122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Columbus, Ohio, United States, 43201
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-
Dayton, Ohio, United States, 45439
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-
Franklin, Ohio, United States, 45005
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-
London, Ohio, United States, 43140
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-
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Oregon
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Bend, Oregon, United States, 97708
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Eugene, Oregon, United States, 97401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Medford, Oregon, United States, 97504
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Portland, Oregon, United States, 97210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Pennsylvania
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Beaver, Pennsylvania, United States, 15009
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Fleetwood, Pennsylvania, United States, 19522
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Levittown, Pennsylvania, United States, 19056
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Philadelphia, Pennsylvania, United States, 19146
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Charleston, South Carolina, United States, 29412
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Greenville, South Carolina, United States, 29605
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Hartsville, South Carolina, United States, 29550
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Tennessee
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Johnson City, Tennessee, United States, 37604
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kingsport, Tennessee, United States, 37660
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Memphis, Tennessee, United States, 38119
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Abilene, Texas, United States, 79601
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Dallas, Texas, United States, 75246
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El Paso, Texas, United States, 79935
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Houston, Texas, United States, 77005
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Killeen, Texas, United States, 76543
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Midland, Texas, United States, 79705
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New Braunfels, Texas, United States, 78130
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San Antonio, Texas, United States, 78229
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Utah
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Ogden, Utah, United States, 84403
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Provo, Utah, United States, 84604
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Vermont
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South Burlington, Vermont, United States, 05403
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Washington
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Bellingham, Washington, United States, 98226
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Everett, Washington, United States, 98208
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Olympia, Washington, United States, 98502
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Renton, Washington, United States, 98057
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Wenatchee, Washington, United States, 98801
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Wisconsin
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Eau Claire, Wisconsin, United States, 54701
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Marshfield, Wisconsin, United States, 54449
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must have type 2 diabetes.
- Must be at least 30 and less than 80 years of age at the time of Visit 1.
- Must be on at least two oral antidiabetes medications for at least 90 days.
- Must have an HbA1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab.
Exclusion Criteria:
- Must not have used insulin on a regular basis in the last 12 months.
- Must not have had more than one episode of severe hypoglycemia in the last 24 weeks.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease.
- Must not be pregnant or intend to get pregnant during course of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Insulin glargine
Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
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Subcutaneous injection daily
Other Names:
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Experimental: Lispro Low Mix
Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
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Subcutaneous injection twice daily.
Other Names:
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Experimental: Lispro Mid Mix prior Lispro Low Mix addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
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Lispro Mid Mix subcutaneous injection 3 times daily.
Other Names:
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Experimental: Lispro Low Mix prior Glargine addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase
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Subcutaneous injection twice daily.
Other Names:
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Active Comparator: Basal bolus prior Lispro Low Mix addendum
Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
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Subcutaneous injection daily
Other Names:
Lispro subcutaneous injection 3 times daily.
Other Names:
|
Active Comparator: Basal bolus prior Glargine addendum
Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, participants could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
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Subcutaneous injection daily
Other Names:
Lispro subcutaneous injection 3 times daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)
Time Frame: Endpoint (Initiation: Week 24)
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Endpoint (Initiation: Week 24)
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MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix)
Time Frame: Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
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HbA1c goal: HbA1c ≤7.0% or HbA1c >7.0% but increased <0.4% from last HbA1c ≤7.0%
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Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)
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ADDENDUM: 24-Week Endpoint HbA1c
Time Frame: Endpoint (Addendum) (24 weeks: Week 48)
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HbA1c at 24-week endpoint in Intensification Addendum of the trial.
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Endpoint (Addendum) (24 weeks: Week 48)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
INITIATION: Change in HbA1c From Baseline to 24 Weeks
Time Frame: Baseline (Initiation) to Endpoint (LOCF, Week 24)
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Baseline (Initiation) to Endpoint (LOCF, Week 24)
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INITIATION: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0%, and HbA1c < or = 6.5% at Endpoint
Time Frame: Endpoint (Initiation: Week 24)
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Endpoint (Initiation: Week 24)
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INITIATION: HbA1c
Time Frame: Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)
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Baseline (Initiation), Week 12, Week 24, Endpoint (LOCF)
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INITIATION: 7-point Self-monitored Plasma Glucose (SMPG) Profiles and Postprandial Excursions
Time Frame: Endpoint (LOCF) (Initiation: Week 24)
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Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial.
A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
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Endpoint (LOCF) (Initiation: Week 24)
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INITIATION: Change From Baseline to Endpoint in 1,5 Anhydroglucitol (1,5 AG)
Time Frame: Baseline (Initiation), Endpoint (Week 24)
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Baseline (Initiation), Endpoint (Week 24)
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INITIATION: Incremental Change From Baseline in Body Weight
Time Frame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
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Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
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INITIATION: Body Weight
Time Frame: Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
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Baseline (Initiation), Weeks 6, 12, 18, 24, Endpoint (LOCF)
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INITIATION: Percentage of Participants With Self-reported Hypoglycemic Episodes
Time Frame: Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
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Hypoglycemia = any time participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L).
Severe hypoglycemia = participant requires assistance.
Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
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Baseline (Initiation), Endpoint (Week 24), Overall (sum of frequencies of hypoglycemic episodes after baseline ([Week 0]).
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INITIATION: Rate of Self-reported Hypoglycemic Episodes
Time Frame: Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
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Hypoglycemia = participant feels/person observes, that participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or glucose measurement ≤70 mg/dL (≤3.9 mmol/L).
Severe hypoglycemia = participant requires assistance.
Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
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Endpoint (Initiation: Week 24), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
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INITIATION: Insulin Dose
Time Frame: Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)
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Weeks 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, Endpoint (LOCF)
|
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Age
Time Frame: Endpoint (Initiation: Week 24)
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Comparison of age at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
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Endpoint (Initiation: Week 24)
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Origin
Time Frame: Endpoint (Initiation: Week 24)
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Comparison of origin at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
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Endpoint (Initiation: Week 24)
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: Endpoint (Initiation: Week 24)
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Comparison of HOMA-IR (surrogate markers of insulin resistance calculated from fasting insulin and glucose) at baseline between those participants who met their goal at Week 24 and those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
HOMA-IR = fasting insulin (milliunits per milliliter) * fasting plasma glucose (millimoles per liter) / 22.5.
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Endpoint (Initiation: Week 24)
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - HbA1c
Time Frame: Endpoint (Initiation: Week 24)
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Comparison of baseline HbA1c between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
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Endpoint (Initiation: Week 24)
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Baseline HbA1c Percentage Group
Time Frame: Endpoint (Initiation: Week 24)
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Comparison of baseline HbA1c percentage group (<8.5,>=8.5)
between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
|
Endpoint (Initiation: Week 24)
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - 1,5 AG
Time Frame: Endpoint (Initiation: Week 24)
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Comparison of 1,5 AG between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
|
Endpoint (Initiation: Week 24)
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal at Week 24 - Pre Meals Blood Glucose, Post Meals Blood Glucose, Average of All Blood Glucose, and Fasting Blood Glucose
Time Frame: Endpoint (Initiation: Week 24)
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Comparison of pre meals blood glucose, post meals blood glucose, average of all blood glucose, and fasting blood glucose between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
|
Endpoint (Initiation: Week 24)
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INITIATION: Participant Demographics of Participants Who Did Versus Did Not Achieve HbA1c Goal - Oral Diabetes Medication at Baseline
Time Frame: Endpoint (Initiation: Week 24)
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Comparison of oral diabetes medication at baseline between those participants who met their goal at Week 24 versus those who did not meet their goal at Week 24 (goal HbA1c ≤7.0%).
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Endpoint (Initiation: Week 24)
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MAINTENANCE: HbA1c at Specified Visits and Endpoint
Time Frame: Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)
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Baseline (Week 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (up to 2.5 years)
|
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MAINTENANCE: 7-point SMPG Profiles and Postprandial Excursions
Time Frame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
|
Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial.
A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
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Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
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MAINTENANCE: Rate of Increase in HbA1c
Time Frame: Endpoint (LOCF) (Maintenance: up to 2.5 years)
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Rate of increase: HbA1c change/time period (month).
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Endpoint (LOCF) (Maintenance: up to 2.5 years)
|
MAINTENANCE: Percentage of Participants With HbA1c < or = 7.0%, HbA1c <7.0, and HbA1c < or = 6.5%
Time Frame: Endpoint (LOCF) (Maintenance: up to 2.5 years)
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Endpoint (LOCF) (Maintenance: up to 2.5 years)
|
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MAINTENANCE: Incremental Change From Baseline in Body Weight
Time Frame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Body Weight
Time Frame: Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Baseline (Week 0), Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Insulin Dose
Time Frame: Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
|
MAINTENANCE: Percentage of Participants With Self-reported Hypoglycemic Episodes
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
|
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L).
Severe hypoglycemia = participant requires assistance.
Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
|
Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline (Week 0)
|
MAINTENANCE: Rate of Self-reported Hypoglycemic Episodes
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
|
Hypoglycemia = participant feels/person observes that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L).
Severe hypoglycemia = participant requires assistance.
Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
|
Endpoint (LOCF) (Maintenance) (up to 2.5 years), Overall (incidence of hypoglycemic episodes after baseline [Week 0])
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MAINTENANCE: Change From Baseline in 1,5-Anhydroglucitol
Time Frame: Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
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Baseline (Maintenance: Week 24), Endpoint (LOCF) (up to 2.5 years)
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MAINTENANCE: Change From Baseline to Endpoint in HbA1c
Time Frame: Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Baseline (Week 0), Week 24, Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of duration of diabetes at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Comparison of duration of diabetes at baseline between those participants taking lispro LM that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
|
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Duration of Diabetes Group
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of duration of diabetes group (<10, 10-<20, >=20 years) at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of baseline HbA1c between those participants taking insulin glargine that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of baseline HbA1c between those participants taking Lispro LM that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
|
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of baseline HbA1c group (<8.5,>=8.5)
between those participants taking insulin glargine that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
|
Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Baseline HbA1c Group
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of baseline HbA1c group (<8.5,>=8.5)
between those participants taking Lispro LM that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Comparison of oral diabetes medication at baseline between those participants taking insulin glargine that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Oral Diabetes Medicine at Baseline
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of oral diabetes medication at baseline between those participants taking Lispro LM that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of baseline 1,5 AG between those participants taking insulin glargine that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - 1,5 AG
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
|
Comparison of baseline 1,5 AG between those participants taking Lispro LM that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Insulin Glargine Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking insulin glargine that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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MAINTENANCE: Participant Demographics of Lispro LM Participants Who Did Versus Did Not Maintain HbA1c Goal - Mean of Post Meals Blood Glucose and Average of All Blood Glucose
Time Frame: Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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Comparison of baseline mean of post meals blood glucose and average of all blood glucose between those participants taking Lispro LM that maintained their HbA1c goal and those that did not.
Participants who maintained goal are those who did not fail during their duration on study.
Failure is defined by HbA1c > 7.0% with change >= 0.4% from most recent HbA1c that was <=7.0%.
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Endpoint (LOCF) (Maintenance) (up to 2.5 years)
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ADDENDUM: Change in HbA1c From Point of Second Randomization (Addendum Baseline) to Endpoint
Time Frame: Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])
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Baseline (Addendum: Week 24), Endpoint (24 weeks [Week 48])
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ADDENDUM: Percentage of Participants With HbA1c < or = 7.0%, HbA1c < 7.0%, and < or = 6.5%
Time Frame: Endpoint (Addendum: 24 weeks [Week 48])
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Endpoint (Addendum: 24 weeks [Week 48])
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ADDENDUM: 7-point SMPG Profiles
Time Frame: Endpoint (Addendum: 24 weeks [Week 48])
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Abbreviations: AM = morning; BG = blood glucose; PM = evening; PP = postprandial.
A postprandial excursion is defined as: 2 hour postmeal plasma glucose-premeal plasma glucose.
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Endpoint (Addendum: 24 weeks [Week 48])
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ADDENDUM: Incremental Change From Baseline in Body Weight
Time Frame: Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)
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Baseline (Addendum: Week 24), Weeks 6 (30 Weeks), 12 (36 Weeks), 24 (48 Weeks), Endpoint (LOCF)
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ADDENDUM: Body Weight
Time Frame: Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
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Baseline (Addendum Week 24), Weeks 6 (30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
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ADDENDUM: Insulin Dose
Time Frame: Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
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Baseline (Addendum: Week 24), Weeks 1 (25 weeks), 2 (26 weeks), 3 (27 weeks), 4 (28 weeks), 5 (25 weeks), 6 (26 weeks), 8 (32 weeks), 10 (34 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
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ADDENDUM: Percentage of Participants With Self-reported Hypoglycemic Episodes
Time Frame: Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
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Hypoglycemia = any time participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L).
Severe hypoglycemia = participant requires assistance.
Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
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Weeks 6 (Addendum: 30 weeks), 12 (36 weeks), 24 (48 weeks), Endpoint (LOCF)
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ADDENDUM: Rate of Self-reported Hypoglycemic Episodes
Time Frame: Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase
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Hypoglycemia = participant feels/person observes, that the participant is experiencing a sign/symptom they associate with hypoglycemia (such as hunger, dizziness, shakiness, light-headedness, sweating, irritability, headache, fast heart beat, confusion, etc) or a glucose measurement ≤70 mg/dL (≤3.9 mmol/L).
Severe hypoglycemia = participant requires assistance.
Qualified medical staff instructed the participants about the signs and symptoms of hypoglycemia.
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Endpoint (Addendum 24 weeks), Overall (mean yearly rate of hypoglycemia during addendum phase
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ADDENDUM: Change From Baseline in 1,5-Anhydroglucitol to Week 24
Time Frame: Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)
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Baseline (addendum: 24 weeks), Endpoint (24 weeks: Week 48)
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ADDENDUM: HbA1c at Specified Visits and Endpoint
Time Frame: Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)
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Baseline (Addendum: 24 weeks), Weeks 12, 24, Endpoint (24 weeks: Week 48)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
- Herman WH, Dungan KM, Wolffenbuttel BH, Buse JB, Fahrbach JL, Jiang H, Martin S. Racial and ethnic differences in mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 May;94(5):1689-94. doi: 10.1210/jc.2008-1940. Epub 2009 Mar 10.
- Fahrbach J, Jacober S, Jiang H, Martin S. The DURABLE trial study design: comparing the safety, efficacy, and durability of insulin glargine to insulin lispro mix 75/25 added to oral antihyperglycemic agents in patients with type 2 diabetes. J Diabetes Sci Technol. 2008 Sep;2(5):831-8. doi: 10.1177/193229680800200514.
- Scheen AJ, Schmitt H, Jiang HH, Ivanyi T. Individualizing treatment of type 2 diabetes by targeting postprandial or fasting hyperglycaemia: Response to a basal vs a premixed insulin regimen by HbA1c quartiles and ethnicity. Diabetes Metab. 2015 Jun;41(3):216-22. doi: 10.1016/j.diabet.2015.03.002. Epub 2015 Apr 14.
- Jovanovic L, Peters AL, Jiang HH, Hardin DS. Durability of glycemic control with insulin lispro mix 75/25 versus insulin glargine for older patients with type 2 diabetes. Aging Clin Exp Res. 2014 Apr;26(2):115-21. doi: 10.1007/s40520-013-0140-8. Epub 2013 Oct 3.
- Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Jiang HH, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013 Oct;36(10):2931-6. doi: 10.2337/dc12-2711. Epub 2013 Jun 11.
- Buse JB, Wolffenbuttel BH, Herman WH, Hippler S, Martin SA, Jiang HH, Shenouda SK, Fahrbach JL. The DURAbility of Basal versus Lispro mix 75/25 insulin Efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine. Diabetes Care. 2011 Feb;34(2):249-55. doi: 10.2337/dc10-1701.
- Miser WF, Arakaki R, Jiang H, Scism-Bacon J, Anderson PW, Fahrbach JL. Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin Ther. 2010 May;32(5):896-908. doi: 10.1016/j.clinthera.2010.05.001.
- Wolffenbuttel BH, Klaff LJ, Bhushan R, Fahrbach JL, Jiang H, Martin S. Initiating insulin therapy in elderly patients with Type 2 diabetes: efficacy and safety of lispro mix 25 vs. basal insulin combined with oral glucose-lowering agents. Diabet Med. 2009 Nov;26(11):1147-55. doi: 10.1111/j.1464-5491.2009.02824.x.
- Buse JB, Wolffenbuttel BH, Herman WH, Shemonsky NK, Jiang HH, Fahrbach JL, Scism-Bacon JL, Martin SA. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1007-13. doi: 10.2337/dc08-2117. Epub 2009 Mar 31.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10455
- F3Z-US-IOOV (Other Identifier: Eli Lilly and Company)
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