A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)
30. april 2019 opdateret af: Novo Nordisk A/S
A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)
This trial is conducted in the United States of America (USA).
The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
721
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35216
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Birmingham, Alabama, Forenede Stater, 35215-7502
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Haleyville, Alabama, Forenede Stater, 35565-1719
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Montgomery, Alabama, Forenede Stater, 36106
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Tuscumbia, Alabama, Forenede Stater, 35674
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
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Phoenix, Arizona, Forenede Stater, 85050
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Tucson, Arizona, Forenede Stater, 85704
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
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California
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Costa Mesa, California, Forenede Stater, 92626
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Downey, California, Forenede Stater, 90242
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El Cajon, California, Forenede Stater, 92020
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Fresno, California, Forenede Stater, 93720
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Fresno, California, Forenede Stater, 93702
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Hawaiian Gardens, California, Forenede Stater, 90716
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Huntington Park, California, Forenede Stater, 90255
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Lincoln, California, Forenede Stater, 95648
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Long Beach, California, Forenede Stater, 90807
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Montclair, California, Forenede Stater, 91763
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North Hollywood, California, Forenede Stater, 91606
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Northridge, California, Forenede Stater, 91325
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Pomona, California, Forenede Stater, 91766-2007
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Poway, California, Forenede Stater, 92064
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Rancho Cucamonga, California, Forenede Stater, 91730-3063
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Rialto, California, Forenede Stater, 92376
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Roseville, California, Forenede Stater, 95661
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San Diego, California, Forenede Stater, 92111
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Santa Monica, California, Forenede Stater, 90404
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Tarzana, California, Forenede Stater, 91356-3551
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Torrance, California, Forenede Stater, 90502
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Tustin, California, Forenede Stater, 92780
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80910
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Golden, Colorado, Forenede Stater, 80401
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Delaware
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Newark, Delaware, Forenede Stater, 19713
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Florida
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Bradenton, Florida, Forenede Stater, 34201
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Chiefland, Florida, Forenede Stater, 32626
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Clearwater, Florida, Forenede Stater, 33765
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Clearwater, Florida, Forenede Stater, 33756
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Cooper City, Florida, Forenede Stater, 33024
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Doral, Florida, Forenede Stater, 33166
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Hialeah, Florida, Forenede Stater, 33012
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Hialeah, Florida, Forenede Stater, 33013
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Jacksonville, Florida, Forenede Stater, 32216
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Jacksonville, Florida, Forenede Stater, 32204
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Jacksonville, Florida, Forenede Stater, 32256
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Jacksonville, Florida, Forenede Stater, 32277
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Miami, Florida, Forenede Stater, 33156
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Miami, Florida, Forenede Stater, 33174
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Miami, Florida, Forenede Stater, 33175
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Miami, Florida, Forenede Stater, 33130
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Miami, Florida, Forenede Stater, 33155
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Miami, Florida, Forenede Stater, 33165
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Miami, Florida, Forenede Stater, 33186
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Miami Springs, Florida, Forenede Stater, 33166
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Miramar, Florida, Forenede Stater, 33027
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New Port Richey, Florida, Forenede Stater, 34652
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Ocala, Florida, Forenede Stater, 34470
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Orlando, Florida, Forenede Stater, 32801
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Panama City, Florida, Forenede Stater, 32401
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Pembroke Pines, Florida, Forenede Stater, 33026
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Tampa, Florida, Forenede Stater, 33607
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Tampa, Florida, Forenede Stater, 33619
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Georgia
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Perry, Georgia, Forenede Stater, 31069
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Illinois
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Champaign, Illinois, Forenede Stater, 61821
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Chicago, Illinois, Forenede Stater, 60611
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Indiana
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Evansville, Indiana, Forenede Stater, 47714
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Muncie, Indiana, Forenede Stater, 47304
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50265
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Kansas
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Lenexa, Kansas, Forenede Stater, 66219
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Newton, Kansas, Forenede Stater, 67114
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
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Lexington, Kentucky, Forenede Stater, 40502
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Louisville, Kentucky, Forenede Stater, 40213
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Paducah, Kentucky, Forenede Stater, 42003
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70119
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Shreveport, Louisiana, Forenede Stater, 71105
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Massachusetts
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Brockton, Massachusetts, Forenede Stater, 02301
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Michigan
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Kalamazoo, Michigan, Forenede Stater, 49009
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Mississippi
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Olive Branch, Mississippi, Forenede Stater, 38654-3573
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Missouri
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Florissant, Missouri, Forenede Stater, 63031
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Jefferson City, Missouri, Forenede Stater, 65109
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Kansas City, Missouri, Forenede Stater, 64106
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Nevada
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Henderson, Nevada, Forenede Stater, 89052-2649
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Las Vegas, Nevada, Forenede Stater, 89148
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New Hampshire
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Newington, New Hampshire, Forenede Stater, 03801
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New Jersey
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Morganville, New Jersey, Forenede Stater, 07751
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Teaneck, New Jersey, Forenede Stater, 07666
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
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New York
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Albany, New York, Forenede Stater, 12208
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Jackson Heights, New York, Forenede Stater, 11372
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New Windsor, New York, Forenede Stater, 12553
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Northport, New York, Forenede Stater, 11768
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Smithtown, New York, Forenede Stater, 11787
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28277
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Morganton, North Carolina, Forenede Stater, 28655
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Winston-Salem, North Carolina, Forenede Stater, 27103
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Ohio
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Delaware, Ohio, Forenede Stater, 43015
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Franklin, Ohio, Forenede Stater, 45005
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Toledo, Ohio, Forenede Stater, 43614
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73103
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Pennsylvania
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Altoona, Pennsylvania, Forenede Stater, 16602
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Beaver, Pennsylvania, Forenede Stater, 15009
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Philadelphia, Pennsylvania, Forenede Stater, 19107
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Philadelphia, Pennsylvania, Forenede Stater, 19114
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Scottdale, Pennsylvania, Forenede Stater, 15683
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South Carolina
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Anderson, South Carolina, Forenede Stater, 29621
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Gaffney, South Carolina, Forenede Stater, 29341
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Greer, South Carolina, Forenede Stater, 29651
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Pelzer, South Carolina, Forenede Stater, 29669
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Spartanburg, South Carolina, Forenede Stater, 29303
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57701
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Tennessee
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Bristol, Tennessee, Forenede Stater, 37620-7352
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Bristol, Tennessee, Forenede Stater, 37620
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Chattanooga, Tennessee, Forenede Stater, 37404
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Humboldt, Tennessee, Forenede Stater, 38343
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Jackson, Tennessee, Forenede Stater, 38305
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Johnson City, Tennessee, Forenede Stater, 37604
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Kingsport, Tennessee, Forenede Stater, 37660
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Texas
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Arlington, Texas, Forenede Stater, 76012-4637
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Arlington, Texas, Forenede Stater, 76012
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Austin, Texas, Forenede Stater, 78758
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Carrollton, Texas, Forenede Stater, 75007
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Dallas, Texas, Forenede Stater, 75208
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El Paso, Texas, Forenede Stater, 79912
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Fort Worth, Texas, Forenede Stater, 76104
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Houston, Texas, Forenede Stater, 77040
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Houston, Texas, Forenede Stater, 77072
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Houston, Texas, Forenede Stater, 77070
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Houston, Texas, Forenede Stater, 77043
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Houston, Texas, Forenede Stater, 77060
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Houston, Texas, Forenede Stater, 77077
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Humble, Texas, Forenede Stater, 77338
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Hurst, Texas, Forenede Stater, 76054
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Marshall, Texas, Forenede Stater, 75670
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Mesquite, Texas, Forenede Stater, 75149
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North Richland Hills, Texas, Forenede Stater, 76180
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Plano, Texas, Forenede Stater, 75075
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Plano, Texas, Forenede Stater, 75093
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Richardson, Texas, Forenede Stater, 75080
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San Antonio, Texas, Forenede Stater, 78229
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San Antonio, Texas, Forenede Stater, 78215
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San Antonio, Texas, Forenede Stater, 78224
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San Antonio, Texas, Forenede Stater, 78240
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San Antonio, Texas, Forenede Stater, 78258
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San Antonio, Texas, Forenede Stater, 78228-3419
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Sealy, Texas, Forenede Stater, 77474
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Sugar Land, Texas, Forenede Stater, 77478
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Sugar Land, Texas, Forenede Stater, 77479
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Victoria, Texas, Forenede Stater, 77901
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Waco, Texas, Forenede Stater, 76710
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Utah
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Draper, Utah, Forenede Stater, 84020
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Ogden, Utah, Forenede Stater, 84405
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Salt Lake City, Utah, Forenede Stater, 84107
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Virginia
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Chesapeake, Virginia, Forenede Stater, 23321
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Norfolk, Virginia, Forenede Stater, 23510
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Washington
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Olympia, Washington, Forenede Stater, 98502
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Renton, Washington, Forenede Stater, 98057
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Richland, Washington, Forenede Stater, 99352
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Spokane, Washington, Forenede Stater, 99202-1334
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West Virginia
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Martinsburg, West Virginia, Forenede Stater, 25401
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Wisconsin
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Kenosha, Wisconsin, Forenede Stater, 53144
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Carolina, Puerto Rico, 00983
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Manati, Puerto Rico, 00674
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Ponce, Puerto Rico, 00717
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San Juan, Puerto Rico, 00921
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San Juan, Puerto Rico, 00918
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes Association) definition, April 2013), b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73
m^2 per CKD-Epi (Chronic Kidney Disease Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Eksperimentel: IDeg OD ± OADs followed by IGlar OD ± OADs
The trial includes two 32-week treatment periods in a cross-over design.
Total trial duration for the individual subjects will be up to 67 weeks.
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Administered once daily injected s.c.
/ subcutaneously (under the skin).
Dose is individually adjusted.
Administered once daily injected s.c.
/ subcutaneously (under the skin).
Dose is individually adjusted.
|
|
Aktiv komparator: IGlar OD ± OADs followed by IDeg OD ± OADs
The trial includes two 32-week treatment periods in a cross-over design.
Total trial duration for the individual subjects will be up to 67 weeks.
|
Administered once daily injected s.c.
/ subcutaneously (under the skin).
Dose is individually adjusted.
Administered once daily injected s.c.
/ subcutaneously (under the skin).
Dose is individually adjusted.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
Tidsramme: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
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Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.
Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
|
After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Andel af forsøgspersoner med en eller flere alvorlige hypoglykæmiske episoder i løbet af vedligeholdelsesperioden
Tidsramme: Efter 16 ugers behandling, i hver behandlingsperiode (uge 16-32 og uge 48-64)
|
Procentdel af forsøgspersoner, der oplevede en eller flere alvorlige hypoglykæmiske episoder i vedligeholdelsesperioden.
Alvorlig hypoglykæmi (i henhold til definitionen af American Diabetes Association 2013): En hypoglykæmisk episode, der kræver assistance fra en anden person til aktivt at administrere kulhydrat, glukagon eller tage andre korrigerende handlinger.
Plasmaglukoseværdier er muligvis ikke tilgængelige under en hændelse, men neurologisk genopretning efter normalisering af plasmaglucose anses for tilstrækkeligt bevis for, at hændelsen blev induceret af en lav plasmaglukosekoncentration.
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Efter 16 ugers behandling, i hver behandlingsperiode (uge 16-32 og uge 48-64)
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Hyppighed af behandlingsudviklede bivirkninger
Tidsramme: I løbet af 32 ugers behandling for hver behandlingsperiode
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Behandlingsudspringende bivirkning blev defineret som en hændelse med startdato på eller efter den første dag af eksponering for randomiseret behandling og senest den sidste dag af randomiseret behandling.
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I løbet af 32 ugers behandling for hver behandlingsperiode
|
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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period
Tidsramme: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
|
Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive.
Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
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After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
|
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Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Tidsramme: Week 32, Week 64
|
Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2).
Week 32 HbA1c value was considered as baseline for calculating change from baseline in HbA1c at week 64.
|
Week 32, Week 64
|
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FPG (Fasting Plasma Glucose)
Tidsramme: week 32, week 64
|
Fasting plasma glucose values at week 32 and week 64.
|
week 32, week 64
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Evans M, Mehta R, Gundgaard J, Chubb B. Cost-Effectiveness of Insulin Degludec vs. Insulin Glargine U100 in Type 1 and Type 2 Diabetes Mellitus in a UK Setting. Diabetes Ther. 2018 Oct;9(5):1919-1930. doi: 10.1007/s13300-018-0478-1. Epub 2018 Aug 10.
- DeVries JH, Bailey TS, Bhargava A, Gerety G, Gumprecht J, Heller S, Lane W, Wysham CH, Zinman B, Bak BA, Hachmann-Nielsen E, Philis-Tsimikas A. Day-to-day fasting self-monitored blood glucose variability is associated with risk of hypoglycaemia in insulin-treated patients with type 1 and type 2 diabetes: A post hoc analysis of the SWITCH Trials. Diabetes Obes Metab. 2019 Mar;21(3):622-630. doi: 10.1111/dom.13565. Epub 2018 Nov 26.
- Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Norgard Troelsen L, Ostoft SH, Philis-Tsimikas A. Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial. Clin Diabetes. 2019 Jan;37(1):73-81. doi: 10.2337/cd18-0016.
- Wysham C, Bhargava A, Chaykin L, de la Rosa R, Handelsman Y, Troelsen LN, Kvist K, Norwood P. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):45-56. doi: 10.1001/jama.2017.7117.
- Heller SR, DeVries JH, Wysham C, Hansen CT, Hansen MV, Frier BM. Lower rates of hypoglycaemia in older individuals with type 2 diabetes using insulin degludec versus insulin glargine U100: Results from SWITCH 2. Diabetes Obes Metab. 2019 Jul;21(7):1634-1641. doi: 10.1111/dom.13708. Epub 2019 Apr 15.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
6. januar 2014
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
4. december 2015
Studieafslutning (Faktiske)
Studieafslutning
4. december 2015
Datoer for studieregistrering
Først indsendt
Først indsendt
7. januar 2014
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
7. januar 2014
Først opslået (Skøn)
Først opslået
8. januar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
10. maj 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. april 2019
Sidst verificeret
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- NN1250-3998
- U1111-1143-7963 (Anden identifikator: WHO)
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