To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c (LEAD-3)
January 24, 2017 updated by: Novo Nordisk A/S
Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes
This trial is conducted in North America (the United States of America (USA) and Mexico).
The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
746
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chihuahua, Chih, Mexico, 31000
- Novo Nordisk Investigational Site
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Ciudad de México, D.F., Mexico, 06100
- Novo Nordisk Investigational Site
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Ciudad de México, D.F., Mexico, 14050
- Novo Nordisk Investigational Site
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Guadalajara, Mexico, 44600
- Novo Nordisk Investigational Site
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Hermosillo, Son., Mexico, 83000
- Novo Nordisk Investigational Site
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Mexico D.F., Mexico, 06700
- Novo Nordisk Investigational Site
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Mexico, D.F., Mexico, 01120
- Novo Nordisk Investigational Site
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Monterrey, N.L., Mexico, 64000
- Novo Nordisk Investigational Site
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Monterrey, NL, Mexico, 66260
- Novo Nordisk Investigational Site
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Santiago de Querétaro, Qro., Mexico, 76178
- Novo Nordisk Investigational Site
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Tampico, Mexico, 80109
- Novo Nordisk Investigational Site
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Jalisco
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Guadalajara, Jalisco, Mexico, 44650
- Novo Nordisk Investigational Site
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Morelos
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Cuernavaca, Morelos, Mexico, 62250
- Novo Nordisk Investigational Site
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Novo Nordisk Investigational Site
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Rio Piedras, Puerto Rico, 00921
- Novo Nordisk Investigational Site
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California
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Concord, California, United States, 94520
- Novo Nordisk Investigational Site
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Escondido, California, United States, 92025
- Novo Nordisk Investigational Site
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Fullerton, California, United States, 92835
- Novo Nordisk Investigational Site
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Inglewood, California, United States, 90301
- Novo Nordisk Investigational Site
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Mission Viejo, California, United States, 92691
- Novo Nordisk Investigational Site
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Orange, California, United States, 92869
- Novo Nordisk Investigational Site
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Santa Barbara, California, United States, 93105
- Novo Nordisk Investigational Site
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Spring Valley, California, United States, 91978
- Novo Nordisk Investigational Site
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Vista, California, United States, 92084
- Novo Nordisk Investigational Site
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Walnut Creek, California, United States, 94598
- Novo Nordisk Investigational Site
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Florida
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Daytona Beach, Florida, United States, 32117
- Novo Nordisk Investigational Site
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Delray Beach, Florida, United States, 33484
- Novo Nordisk Investigational Site
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Jacksonville, Florida, United States, 32216
- Novo Nordisk Investigational Site
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Jacksonville, Florida, United States, 32205
- Novo Nordisk Investigational Site
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Longwood, Florida, United States, 32779
- Novo Nordisk Investigational Site
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Ocala, Florida, United States, 34471
- Novo Nordisk Investigational Site
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St. Cloud, Florida, United States, 34769
- Novo Nordisk Investigational Site
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Georgia
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Athens, Georgia, United States, 30606
- Novo Nordisk Investigational Site
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Atlanta, Georgia, United States, 30318
- Novo Nordisk Investigational Site
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Atlanta, Georgia, United States, 30339
- Novo Nordisk Investigational Site
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Atlanta, Georgia, United States, 30032
- Novo Nordisk Investigational Site
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Atlanta, Georgia, United States, 30034
- Novo Nordisk Investigational Site
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Blue Ridge, Georgia, United States, 30513
- Novo Nordisk Investigational Site
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Columbus, Georgia, United States, 31904
- Novo Nordisk Investigational Site
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Marietta, Georgia, United States, 30060
- Novo Nordisk Investigational Site
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Powder Springs, Georgia, United States, 30127
- Novo Nordisk Investigational Site
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Tucker, Georgia, United States, 30084
- Novo Nordisk Investigational Site
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Novo Nordisk Investigational Site
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Illinois
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Chicago, Illinois, United States, 60607
- Novo Nordisk Investigational Site
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Chicago, Illinois, United States, 60611
- Novo Nordisk Investigational Site
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Maywood, Illinois, United States, 60153
- Novo Nordisk Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46202
- Novo Nordisk Investigational Site
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Iowa
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Des Moines, Iowa, United States, 50314
- Novo Nordisk Investigational Site
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Kansas
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Shawnee Mission, Kansas, United States, 66204
- Novo Nordisk Investigational Site
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Topeka, Kansas, United States, 66606
- Novo Nordisk Investigational Site
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Kentucky
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Lexington, Kentucky, United States, 40503
- Novo Nordisk Investigational Site
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Lexington, Kentucky, United States, 40536
- Novo Nordisk Investigational Site
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Novo Nordisk Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21218
- Novo Nordisk Investigational Site
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Hyattsville, Maryland, United States, 20782
- Novo Nordisk Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Novo Nordisk Investigational Site
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St. Paul, Minnesota, United States, 55108
- Novo Nordisk Investigational Site
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Mississippi
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Jackson, Mississippi, United States, 39216
- Novo Nordisk Investigational Site
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Tupelo, Mississippi, United States, 38801
- Novo Nordisk Investigational Site
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Missouri
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Chesterfield, Missouri, United States, 63017
- Novo Nordisk Investigational Site
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St. Louis, Missouri, United States, 63110
- Novo Nordisk Investigational Site
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St. Louis, Missouri, United States, 63104
- Novo Nordisk Investigational Site
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St. Peters, Missouri, United States, 63376
- Novo Nordisk Investigational Site
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Montana
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Butte, Montana, United States, 59701
- Novo Nordisk Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68114
- Novo Nordisk Investigational Site
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Nevada
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Reno, Nevada, United States, 89502
- Novo Nordisk Investigational Site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Novo Nordisk Investigational Site
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Lawrenceville, New Jersey, United States, 08648
- Novo Nordisk Investigational Site
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Plainsboro, New Jersey, United States, 08536
- Novo Nordisk Investigational Site
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New York
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Albany, New York, United States, 12206
- Novo Nordisk Investigational Site
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Lewiston, New York, United States, 14092
- Novo Nordisk Investigational Site
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New York, New York, United States, 10023
- Novo Nordisk Investigational Site
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Northport, New York, United States, 11768
- Novo Nordisk Investigational Site
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Staten Island, New York, United States, 10301
- Novo Nordisk Investigational Site
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Syracuse, New York, United States, 13210
- Novo Nordisk Investigational Site
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West Seneca, New York, United States, 14224
- Novo Nordisk Investigational Site
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North Carolina
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Asheville, North Carolina, United States, 28803
- Novo Nordisk Investigational Site
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Charlotte, North Carolina, United States, 28277
- Novo Nordisk Investigational Site
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Durham, North Carolina, United States, 27710
- Novo Nordisk Investigational Site
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Greensboro, North Carolina, United States, 27408
- Novo Nordisk Investigational Site
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Ohio
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Cleveland, Ohio, United States, 44195
- Novo Nordisk Investigational Site
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Dayton, Ohio, United States, 45439
- Novo Nordisk Investigational Site
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Mentor, Ohio, United States, 44060
- Novo Nordisk Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- Novo Nordisk Investigational Site
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Oklahoma City, Oklahoma, United States, 73104
- Novo Nordisk Investigational Site
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Tulsa, Oklahoma, United States, 74104
- Novo Nordisk Investigational Site
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Oregon
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Bend, Oregon, United States, 97710
- Novo Nordisk Investigational Site
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Eugene, Oregon, United States, 97401
- Novo Nordisk Investigational Site
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Medford, Oregon, United States, 97504-8491
- Novo Nordisk Investigational Site
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Medford, Oregon, United States, 97504
- Novo Nordisk Investigational Site
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Pennsylvania
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Lancaster, Pennsylvania, United States, 17601
- Novo Nordisk Investigational Site
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Norristown, Pennsylvania, United States, 19401
- Novo Nordisk Investigational Site
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Philadelphia, Pennsylvania, United States, 19107
- Novo Nordisk Investigational Site
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Rhode Island
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East Providence, Rhode Island, United States, 02914
- Novo Nordisk Investigational Site
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South Carolina
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Greer, South Carolina, United States, 29651
- Novo Nordisk Investigational Site
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Spartanburg, South Carolina, United States, 29303
- Novo Nordisk Investigational Site
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Tennessee
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Chattanooga, Tennessee, United States, 37411
- Novo Nordisk Investigational Site
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Texas
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Arlington, Texas, United States, 76014
- Novo Nordisk Investigational Site
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Corpus Christi, Texas, United States, 78412
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75230
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75231
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75246
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75208
- Novo Nordisk Investigational Site
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Dallas, Texas, United States, 75224
- Novo Nordisk Investigational Site
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Houston, Texas, United States, 77024
- Novo Nordisk Investigational Site
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Houston, Texas, United States, 77074
- Novo Nordisk Investigational Site
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Houston, Texas, United States, 77030
- Novo Nordisk Investigational Site
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Houston, Texas, United States, 77025
- Novo Nordisk Investigational Site
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Midland, Texas, United States, 79707
- Novo Nordisk Investigational Site
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San Antonio, Texas, United States, 78229
- Novo Nordisk Investigational Site
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Utah
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Salt Lake City, Utah, United States, 84132
- Novo Nordisk Investigational Site
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Virginia
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Richmond, Virginia, United States, 23249
- Novo Nordisk Investigational Site
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Washington
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Edmonds, Washington, United States, 98026-7610
- Novo Nordisk Investigational Site
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Olympia, Washington, United States, 98502
- Novo Nordisk Investigational Site
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Renton, Washington, United States, 98057
- Novo Nordisk Investigational Site
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Spokane, Washington, United States, 99218
- Novo Nordisk Investigational Site
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Tacoma, Washington, United States, 98405
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes
- TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
- Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
- OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
- Body Mass Index (BMI) less than or equal to 45 kg/m^2
Exclusion Criteria:
- Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
- Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
- Any serious medical condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Lira 1.8
Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).
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1.2 mg for s.c.
(under the skin) injection
1.8 mg for s.c.
(under the skin) injection
Glimepiride placebo, 8mg capsule
Liraglutide placebo, 200 mcl
Liraglutide placebo, 300 mcl
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EXPERIMENTAL: Lira 1.2
Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).
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1.2 mg for s.c.
(under the skin) injection
1.8 mg for s.c.
(under the skin) injection
Glimepiride placebo, 8mg capsule
Liraglutide placebo, 200 mcl
Liraglutide placebo, 300 mcl
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ACTIVE_COMPARATOR: Glimepiride - 1
Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
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Glimepiride placebo, 8mg capsule
Liraglutide placebo, 200 mcl
Liraglutide placebo, 300 mcl
8 mg capsule
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ACTIVE_COMPARATOR: Glimepiride - 2
Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
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Glimepiride placebo, 8mg capsule
Liraglutide placebo, 200 mcl
Liraglutide placebo, 300 mcl
8 mg capsule
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Time Frame: week 0, week 52
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Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 52 weeks (end of double-blind period)
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week 0, week 52
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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 104
Time Frame: week 0, week 104
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Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 104 weeks (end of 52-week extension)
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week 0, week 104
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Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 156
Time Frame: week 0, week 156
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Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 156 weeks
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week 0, week 156
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Body Weight at Week 52
Time Frame: week 0, week 52
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Change in body weight from baseline (week 0) to 52 weeks (end of double-blind period)
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week 0, week 52
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Change in Body Weight at Week 104
Time Frame: week 0, week 104
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Change in body weight from baseline (week 0) to 104 weeks (end of 52-week extension)
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week 0, week 104
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Change in Body Weight at Week 156
Time Frame: week 0, week 156
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Change in body weight from baseline (week 0) to 156 weeks
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week 0, week 156
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Change in Fasting Plasma Glucose at Week 52
Time Frame: week 0, week 52
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Change in fasting plasma glucose (FPG) from baseline (week 0) to 52 weeks (end of double-blind period)
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week 0, week 52
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Change in Fasting Plasma Glucose at Week 104
Time Frame: week 0, week 104
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Change in fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of 52-week extension)
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week 0, week 104
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Change in Fasting Plasma Glucose at Week 156
Time Frame: week 0, week 156
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Change in fasting plasma glucose (FPG) from baseline (week 0) to 156 weeks
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week 0, week 156
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Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Time Frame: week 0, week 52
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Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 52 weeks (end of double-blind period).
The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
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week 0, week 52
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Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Time Frame: week 0, week 104
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Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of 52-week extension).
The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
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week 0, week 104
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Change in Mean Postprandial Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Time Frame: week 0, week 156
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Change in mean postprandial glucose (PPG) based on self-measured 8-point plasma glucose profiles from baseline (week 0) to 156 weeks.
The 8 time points for self-measurements of plasma glucose were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
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week 0, week 156
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Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 52
Time Frame: week 0, week 52
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Change in mean prandial increments of plasma glucose from baseline (week 0) to 52 weeks (end of double-blind period).
The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
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week 0, week 52
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Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 104
Time Frame: week 0, week 104
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Change in mean prandial increments of plasma glucose from baseline (week 0) to 104 weeks (end of 52-week extension).
The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
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week 0, week 104
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Change in Prandial Increments of Plasma Glucose Based on Self-measured 8-point Plasma Glucose Profiles at Week 156
Time Frame: week 0, week 156
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Change in mean prandial increments (incr.) of plasma glucose from baseline (week 0) to 156 weeks.
The 8 time points for self-measured 8-point plasma glucose profiles were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner), at bedtime, and at 3:00 AM ± 30 min.
Mean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between post- and pre-meal values (for breakfast, lunch and dinner) divided by three.
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week 0, week 156
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Hypoglycaemic Episodes
Time Frame: weeks 0-104
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Total number of hypoglycaemic episodes occuring from baseline (week 0) to 104 weeks (end of the 52-week extension).
Hypoglycaemic episodes were defined as major, minor, or symptoms only.
Major if the subject was unable to treat her/himself.
Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL.
Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
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weeks 0-104
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Hypoglycaemic Episodes
Time Frame: weeks 104-195
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Total number of hypoglycaemic episodes occuring from week 104 to end of trial (week 195).
Hypoglycaemic episodes were defined as major, minor, or symptoms only.
Major if the subject was unable to treat her/himself.
Minor if subject was able to treat her/himself and plasma glucose was below 56 mg/dL.
Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 56 mg/dL.
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weeks 104-195
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.
- McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.
- Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x.
- Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen K, During M, Zdravkovic M, Strauss BJ, Garber AJ; LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163-72. doi: 10.1111/j.1463-1326.2009.01158.x.
- Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.
- Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.
- Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.
- Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.
- Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.
- Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
- King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.
- Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.
- Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.
- Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.
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Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (ACTUAL)
November 1, 2008
Study Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
February 20, 2006
First Submitted That Met QC Criteria
February 20, 2006
First Posted (ESTIMATE)
February 22, 2006
Study Record Updates
Last Update Posted (ACTUAL)
March 7, 2017
Last Update Submitted That Met QC Criteria
January 24, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Anti-Arrhythmia Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Incretins
- Liraglutide
- Glimepiride
Other Study ID Numbers
- NN2211-1573
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.