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Clinical Trial Details

Trial ID: L6929
Source ID: NCT02054897
Associated Drug: Semaglutide
Title: Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes
Acronym: SUSTAIN™1
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02054897/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: placebo
Outcome Measures: Primary: Change in HbA1c (Glycosylated Haemoglobin), Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit., Week 0, week 30 | Secondary: Change in Body Weight, Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit., Week 0, week 30|Change in Fasting Plasma Glucose (FPG), Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit., Week 0, week 30|Change in Systolic and Diastolic Blood Pressure, Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit., Week 0, week 30|Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target, Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit., At 30 weeks of treatment|Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target, Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit., At 30 weeks of treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 388
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-02-03
Completion Date: 2015-05-08
Results First Posted: 2018-01-23
Last Update Posted: 2019-06-12
Locations: Novo Nordisk Investigational Site, Anniston, Alabama, 36207, United States|Novo Nordisk Investigational Site, Birmingham, Alabama, 35216, United States|Novo Nordisk Investigational Site, Pell City, Alabama, 35128, United States|Novo Nordisk Investigational Site, Hawaiian Gardens, California, 90716, United States|Novo Nordisk Investigational Site, Lomita, California, 90717, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Montclair, California, 91763, United States|Novo Nordisk Investigational Site, Northridge, California, 91324, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80920, United States|Novo Nordisk Investigational Site, Boynton Beach, Florida, 33472, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32277, United States|Novo Nordisk Investigational Site, Miami Lakes, Florida, 33016, United States|Novo Nordisk Investigational Site, Miami, Florida, 33015, United States|Novo Nordisk Investigational Site, Miami, Florida, 33143, United States|Novo Nordisk Investigational Site, Miami, Florida, 33144, United States|Novo Nordisk Investigational Site, Miami, Florida, 33173, United States|Novo Nordisk Investigational Site, Miami, Florida, 33174, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33026, United States|Novo Nordisk Investigational Site, Savannah, Georgia, 31406, United States|Novo Nordisk Investigational Site, Brownsburg, Indiana, 46112, United States|Novo Nordisk Investigational Site, Franklin, Indiana, 46131, United States|Novo Nordisk Investigational Site, Wichita, Kansas, 67226, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40504, United States|Novo Nordisk Investigational Site, Olive Branch, Mississippi, 38654, United States|Novo Nordisk Investigational Site, Billings, Montana, 59101, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68144, United States|Novo Nordisk Investigational Site, Belvidere, New Jersey, 07823, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87102, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, Whiteville, North Carolina, 28472, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45255, United States|Novo Nordisk Investigational Site, Delaware, Ohio, 43015, United States|Novo Nordisk Investigational Site, Levittown, Pennsylvania, 19056, United States|Novo Nordisk Investigational Site, Spartanburg, South Carolina, 29303, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Sealy, Texas, 77474, 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, Vancouver, British Columbia, V6J 1S3, Canada|Novo Nordisk Investigational Site, Winnipeg, Manitoba, R2V 4W3, Canada|Novo Nordisk Investigational Site, London, Ontario, N6P 1A9, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M3J 1N2, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H4A 3T2, Canada|Novo Nordisk Investigational Site, Pointe-Claire, Quebec, H9R 4S3, Canada|Novo Nordisk Investigational Site, Trois Rivières, Quebec, G8T 7A1, Canada|Novo Nordisk Investigational Site, Catania, 95122, Italy|Novo Nordisk Investigational Site, Pisa, 56124, Italy|Novo Nordisk Investigational Site, Roma, 00133, Italy|Novo Nordisk Investigational Site, Rome, 00168, Italy|Novo Nordisk Investigational Site, Siena, 53100, Italy|Novo Nordisk Investigational Site, Terni, 05100, Italy|Novo Nordisk Investigational Site, Kyoto-shi, Kyoto, 606-8507, Japan|Novo Nordisk Investigational Site, Suita-shi, Osaka, 565-0853, Japan|Novo Nordisk Investigational Site, Tokyo, 103-0027, Japan|Novo Nordisk Investigational Site, Tokyo, 103-0028, Japan|Novo Nordisk Investigational Site, Tokyo, 160-0008, Japan|Novo Nordisk Investigational Site, Monterrey, Nuevo León, 64620, Mexico|Novo Nordisk Investigational Site, Ciudad Madero, Tamaulipas, 89440, Mexico|Novo Nordisk Investigational Site, Aguascalientes, 20230, Mexico|Novo Nordisk Investigational Site, Oradea, Bihor, 410469, Romania|Novo Nordisk Investigational Site, Bucharest, 010507, Romania|Novo Nordisk Investigational Site, Bucharest, 13682, Romania|Novo Nordisk Investigational Site, Buzau, 120203, Romania|Novo Nordisk Investigational Site, Galati, 800578, Romania|Novo Nordisk Investigational Site, Arkhangelsk, 163001, Russian Federation|Novo Nordisk Investigational Site, Arkhangelsk, 163045, Russian Federation|Novo Nordisk Investigational Site, Chelyabinsk, 454048, Russian Federation|Novo Nordisk Investigational Site, Kazan, 420073, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, 630047, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194358, Russian Federation|Novo Nordisk Investigational Site, Saint-Petesburg, 195257, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410053, Russian Federation|Novo Nordisk Investigational Site, Stavropol, 355035, Russian Federation|Novo Nordisk Investigational Site, Port Elizabeth, Eastern Cape, 6014, South Africa|Novo Nordisk Investigational Site, Bloemfontein, Free State, 9301, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1818, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1827, South Africa|Novo Nordisk Investigational Site, Krugersdorp, Gauteng, 1739, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0084, South Africa|Novo Nordisk Investigational Site, Sophiatown, Gauteng, 2129, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4450, South Africa|Novo Nordisk Investigational Site, Umkomaas, KwaZulu-Natal, 4170, South Africa|Novo Nordisk Investigational Site, Cardiff, CF5 4AD, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD2 5NH, United Kingdom|Novo Nordisk Investigational Site, St Helens, WA9 3DA, United Kingdom|Novo Nordisk Investigational Site, Swansea, SA2 8PP, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02054897

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress