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Clinical Trial Details

Trial ID: L3899
Source ID: NCT01885208
Associated Drug: Semaglutide
Title: Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes
Acronym: SUSTAIN™ 3
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01885208/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: exenatide
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin), Mean change in HbA1c from baseline to week 56., Week 0, week 56 | Secondary: Change From Baseline in Body Weight, Mean change in body weight from baseline to week 56., Week 0, week 56|Change From Baseline in Fasting Plasma Glucose (FPG), Mean change in FPG from baseline to week 56., Week 0, week 56|Change From Baseline in Systolic and Diastolic Blood Pressure, Mean changes in systolic and diastolic blood pressure from baseline to week 56., Week 0, week 56|Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs), The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value 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., Week 0, week 56|Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no), The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment., After 56 weeks' treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 813
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-12-02
Completion Date: 2015-07-13
Results First Posted: 2018-03-30
Last Update Posted: 2019-06-13
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, Glendale, Arizona, 85306-4652, United States|Novo Nordisk Investigational Site, Mesa, Arizona, 85213, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85027, United States|Novo Nordisk Investigational Site, Burbank, California, 91505, 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, 90017, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90022, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Northridge, California, 91324, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, San Diego, California, 92108, United States|Novo Nordisk Investigational Site, Tustin, California, 92780, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80906, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80909, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Brandon, Florida, 33511, United States|Novo Nordisk Investigational Site, Coral Gables, Florida, 33134, United States|Novo Nordisk Investigational Site, Hialeah, Florida, 33012, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32207, United States|Novo Nordisk Investigational Site, Miami Lakes, Florida, 33016, United States|Novo Nordisk Investigational Site, Miami, Florida, 33144, United States|Novo Nordisk Investigational Site, Miami, Florida, 33145, United States|Novo Nordisk Investigational Site, Miami, Florida, 33174, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Savannah, Georgia, 31406, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60634, United States|Novo Nordisk Investigational Site, Franklin, Indiana, 46131, United States|Novo Nordisk Investigational Site, Greenfield, Indiana, 46140, United States|Novo Nordisk Investigational Site, Muncie, Indiana, 47304, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, Madisonville, Kentucky, 42431, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Kalamazoo, Michigan, 49009, United States|Novo Nordisk Investigational Site, Saint Louis, Missouri, 63141, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89103, United States|Novo Nordisk Investigational Site, Mine Hill, New Jersey, 07803, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87102, United States|Novo Nordisk Investigational Site, North Massapequa, New York, 11758-1802, United States|Novo Nordisk Investigational Site, Syracuse, New York, 13210, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Hickory, North Carolina, 28601, United States|Novo Nordisk Investigational Site, Whiteville, North Carolina, 28472, United States|Novo Nordisk Investigational Site, Akron, Ohio, 44311, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45255, United States|Novo Nordisk Investigational Site, Cleveland, Ohio, 44122, United States|Novo Nordisk Investigational Site, Delaware, Ohio, 43015, United States|Novo Nordisk Investigational Site, Corvallis, Oregon, 97330-3737, United States|Novo Nordisk Investigational Site, Portland, Oregon, 97210, United States|Novo Nordisk Investigational Site, Portland, Oregon, 97239, United States|Novo Nordisk Investigational Site, Lansdale, Pennsylvania, 19446-1002, United States|Novo Nordisk Investigational Site, Norristown, Pennsylvania, 19401, United States|Novo Nordisk Investigational Site, Charleston, South Carolina, 29407, United States|Novo Nordisk Investigational Site, Mount Pleasant, South Carolina, 29464, United States|Novo Nordisk Investigational Site, Murrells Inlet, South Carolina, 29576, United States|Novo Nordisk Investigational Site, Spartanburg, South Carolina, 29303, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Carrollton, Texas, 75010, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75225, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-8858, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76117, United States|Novo Nordisk Investigational Site, Houston, Texas, 77008, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Houston, Texas, 77040, United States|Novo Nordisk Investigational Site, Houston, Texas, 77072, United States|Novo Nordisk Investigational Site, Irving, Texas, 75039, United States|Novo Nordisk Investigational Site, Katy, Texas, 77450, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78245, 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, Alexandria, Virginia, 22304, United States|Novo Nordisk Investigational Site, Buenos Aires, C1250AAN, Argentina|Novo Nordisk Investigational Site, Buenos Aires, C1425AGC, Argentina|Novo Nordisk Investigational Site, Caba, C1179AAB, Argentina|Novo Nordisk Investigational Site, Lanus Este, B1824KAJ, Argentina|Novo Nordisk Investigational Site, Mar del Plata, B7600GWV, Argentina|Novo Nordisk Investigational Site, Karlovac, 47000, Croatia|Novo Nordisk Investigational Site, Osijek, 31 000, Croatia|Novo Nordisk Investigational Site, Slavonski Brod, 35 000, Croatia|Novo Nordisk Investigational Site, Virovitica, 33000, Croatia|Novo Nordisk Investigational Site, Zagreb, 10 000, Croatia|Novo Nordisk Investigational Site, Helsinki, 00260, Finland|Novo Nordisk Investigational Site, Helsinki, FI-00100, Finland|Novo Nordisk Investigational Site, Kerava, FI-04200, Finland|Novo Nordisk Investigational Site, Oulu, 90220, Finland|Novo Nordisk Investigational Site, Turku, 20520, Finland|Novo Nordisk Investigational Site, Chalons-en-Champagne Cedex, 51005, France|Novo Nordisk Investigational Site, Corbeil Essonnes, 91106, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, Nanterre, 92014, France|Novo Nordisk Investigational Site, Roubaix, 59100, France|Novo Nordisk Investigational Site, Strasbourg, 67000, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Dresden, 01219, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Duisburg, 47051, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Mannheim, 68163, Germany|Novo Nordisk Investigational Site, Oldenburg, 23758, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Völklingen, 66333, Germany|Novo Nordisk Investigational Site, Athens, GR-12462, Greece|Novo Nordisk Investigational Site, Athens, GR-14233, Greece|Novo Nordisk Investigational Site, Athens, GR-17562, Greece|Novo Nordisk Investigational Site, Piraeus, GR-18536, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54636, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57010, Greece|Novo Nordisk Investigational Site, Bologna, 40138, Italy|Novo Nordisk Investigational Site, Città di Castello, 06012, Italy|Novo Nordisk Investigational Site, Milano, 20132, Italy|Novo Nordisk Investigational Site, Palermo, 90127, Italy|Novo Nordisk Investigational Site, Pavia, 27100, Italy|Novo Nordisk Investigational Site, Roma, 00161, Italy|Novo Nordisk Investigational Site, Siena, 53100, Italy|Novo Nordisk Investigational Site, Amsterdam, 1066 EC, Netherlands|Novo Nordisk Investigational Site, Apeldoorn, 7334 DZ, Netherlands|Novo Nordisk Investigational Site, Delft, 2625 AD, Netherlands|Novo Nordisk Investigational Site, Hoofddorp, 2134 TM, Netherlands|Novo Nordisk Investigational Site, Leeuwarden, 8934 AD, Netherlands|Novo Nordisk Investigational Site, Rotterdam, 3021 HC, Netherlands|Novo Nordisk Investigational Site, Rotterdam, 3039 BD, Netherlands|Novo Nordisk Investigational Site, Venlo, 5912 BL, Netherlands|Novo Nordisk Investigational Site, Zoetermeer, 2725 NA, Netherlands|Novo Nordisk Investigational Site, Caguas, 00725, Puerto Rico|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Belgrade, 11080, Serbia|Novo Nordisk Investigational Site, Kragujevac, 34000, Serbia|Novo Nordisk Investigational Site, Novi Sad, 21000, Serbia|Novo Nordisk Investigational Site, Basel, 4031, Switzerland|Novo Nordisk Investigational Site, Genève 14, 1211, Switzerland|Novo Nordisk Investigational Site, Luzern 16, 6000, Switzerland|Novo Nordisk Investigational Site, St. Gallen, 9007, Switzerland|Novo Nordisk Investigational Site, Zollikerberg, 8125, Switzerland|Novo Nordisk Investigational Site, Ayr, KA6 6DX, United Kingdom|Novo Nordisk Investigational Site, Bath, BA1 3NG, United Kingdom|Novo Nordisk Investigational Site, Bradford-on-Avon, BA15 1DQ, United Kingdom|Novo Nordisk Investigational Site, Haxey, DN9 2HY, United Kingdom|Novo Nordisk Investigational Site, Headington, OX3 7LE, United Kingdom|Novo Nordisk Investigational Site, Rotherham, S651DA, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01885208

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress