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Clinical Trial Details

Trial ID: L6064
Source ID: NCT02305381
Associated Drug: Semaglutide
Title: Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes
Acronym: SUSTAIN™ 5
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02305381/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: placebo
Outcome Measures: Primary: Change in HbA1c (Glycosylated Haemoglobin), Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements., Week 0, week 30 | Secondary: Change in Body Weight, Estimated mean change from baseline in body weight at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements., Week 0, week 30|Change in Fasting Plasma Glucose (FPG), Estimated mean change from baseline in FPG at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements., week 0, week 30|Change in Insulin Dose, Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. Responses at week 30 are analysed using an Analysis of covariance model with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward., week 0, week 30|Change in Systolic and Diastolic Blood Pressure, Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements., week 0, week 30|Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ), The DTSQs questionnaire was used to assess subjects' treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] and use of metformin \[yes or no\]) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward., week 0, week 30|HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target, Percentage of subjects with HbA1C below 7.0% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit., After 30 weeks treatment|HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target, Percentage of participants with HbA1c below or equal to 6.5% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit., After 30 weeks treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 397
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-12-01
Completion Date: 2015-11-21
Results First Posted: 2018-02-19
Last Update Posted: 2019-06-11
Locations: Novo Nordisk Investigational Site, Phoenix, Arizona, 85018, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Lomita, California, 90717, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057-3550, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, Poway, California, 92064, United States|Novo Nordisk Investigational Site, Riverside, California, 92506, United States|Novo Nordisk Investigational Site, Roseville, California, 95661, United States|Novo Nordisk Investigational Site, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Van Nuys, California, 91405, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06708, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Fleming Island, Florida, 32003, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32204, United States|Novo Nordisk Investigational Site, Port Charlotte, Florida, 33952, United States|Novo Nordisk Investigational Site, Spring Hill, Florida, 34609, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33634, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60611, United States|Novo Nordisk Investigational Site, Gillespie, Illinois, 62033, United States|Novo Nordisk Investigational Site, Skokie, Illinois, 60077, United States|Novo Nordisk Investigational Site, Avon, Indiana, 46123, United States|Novo Nordisk Investigational Site, Greenfield, Indiana, 46140, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Muncie, Indiana, 47304, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, Overland Park, Kansas, 66209, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Paducah, Kentucky, 42003, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453, United States|Novo Nordisk Investigational Site, Ann Arbor, Michigan, 48106, United States|Novo Nordisk Investigational Site, Flint, Michigan, 48532, United States|Novo Nordisk Investigational Site, Kalamazoo, Michigan, 49009, United States|Novo Nordisk Investigational Site, Jackson, Mississippi, 39209, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89103, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89128, United States|Novo Nordisk Investigational Site, Teaneck, New Jersey, 07666, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87102, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45246, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45255, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Kettering, Ohio, 45429, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73162-4704, United States|Novo Nordisk Investigational Site, Yukon, Oklahoma, 73099, United States|Novo Nordisk Investigational Site, Levittown, Pennsylvania, 19056-2404, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19114, United States|Novo Nordisk Investigational Site, Athens, Tennessee, 37303, United States|Novo Nordisk Investigational Site, Bristol, Tennessee, 37620-7352, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76132, United States|Novo Nordisk Investigational Site, Houston, Texas, 77008, United States|Novo Nordisk Investigational Site, Hurst, Texas, 76054, United States|Novo Nordisk Investigational Site, Katy, Texas, 77450, United States|Novo Nordisk Investigational Site, Mesquite, Texas, 75149, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78224, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77479, United States|Novo Nordisk Investigational Site, Bountiful, Utah, 84010, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23219, United States|Novo Nordisk Investigational Site, Kenosha, Wisconsin, 53144, United States|Novo Nordisk Investigational Site, Essen, 45219, Germany|Novo Nordisk Investigational Site, Falkensee, 14612, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Hamburg, 21073, Germany|Novo Nordisk Investigational Site, Hamburg, 22587, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Stuttgart, 70378, Germany|Novo Nordisk Investigational Site, Sulzbach-Rosenberg, 92237, Germany|Novo Nordisk Investigational Site, Ibaraki, 311-0113, Japan|Novo Nordisk Investigational Site, Kashiwara-shi, Osaka, 582-0005, Japan|Novo Nordisk Investigational Site, Kumamoto-shi, Kumamoto, 860-0811, Japan|Novo Nordisk Investigational Site, Miyazaki, 880-0034, Japan|Novo Nordisk Investigational Site, Osaka, 569-1045, Japan|Novo Nordisk Investigational Site, Tokyo, 103-0027, Japan|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Kragujevac, 34000, Serbia|Novo Nordisk Investigational Site, Novi Sad, 21000, Serbia|Novo Nordisk Investigational Site, Bratislava, 833 05, Slovakia|Novo Nordisk Investigational Site, Kosice, 040 01, Slovakia|Novo Nordisk Investigational Site, Levice, 93401, Slovakia|Novo Nordisk Investigational Site, Lucenec, 984 01, Slovakia|Novo Nordisk Investigational Site, Presov, 080 01, Slovakia
URL: https://clinicaltrials.gov/show/NCT02305381

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress