Diabetes Mellitus, Type 2 Clinical Trial
— SUSTAIN™ 3Official 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 (SUSTAIN™ 3 - vs. QW GLP-1)
| Verified date | May 2019 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.
| Status | Completed |
| Enrollment | 813 |
| Est. completion date | July 13, 2015 |
| Est. primary completion date | July 13, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Caba | |
| Argentina | Novo Nordisk Investigational Site | Lanus Este | |
| Argentina | Novo Nordisk Investigational Site | Mar del Plata | |
| Croatia | Novo Nordisk Investigational Site | Karlovac | |
| Croatia | Novo Nordisk Investigational Site | Osijek | |
| Croatia | Novo Nordisk Investigational Site | Slavonski Brod | |
| Croatia | Novo Nordisk Investigational Site | Virovitica | |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Kerava | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| Finland | Novo Nordisk Investigational Site | Turku | |
| France | Novo Nordisk Investigational Site | Chalons-en-Champagne Cedex | |
| France | Novo Nordisk Investigational Site | Corbeil Essonnes | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Le Creusot | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Roubaix | |
| France | Novo Nordisk Investigational Site | Strasbourg | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Duisburg | |
| Germany | Novo Nordisk Investigational Site | Hohenmölsen | |
| Germany | Novo Nordisk Investigational Site | Mannheim | |
| Germany | Novo Nordisk Investigational Site | Oldenburg | |
| Germany | Novo Nordisk Investigational Site | Rehlingen-Siersburg | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Athens | |
| Greece | Novo Nordisk Investigational Site | Piraeus | |
| Greece | Novo Nordisk Investigational Site | Thessaloniki | |
| Greece | Novo Nordisk Investigational Site | Thessaloniki | |
| Italy | Novo Nordisk Investigational Site | Bologna | |
| Italy | Novo Nordisk Investigational Site | Città di Castello | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Palermo | |
| Italy | Novo Nordisk Investigational Site | Pavia | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Siena | |
| Netherlands | Novo Nordisk Investigational Site | Amsterdam | |
| Netherlands | Novo Nordisk Investigational Site | Apeldoorn | |
| Netherlands | Novo Nordisk Investigational Site | Delft | |
| Netherlands | Novo Nordisk Investigational Site | Hoofddorp | |
| Netherlands | Novo Nordisk Investigational Site | Leeuwarden | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| Netherlands | Novo Nordisk Investigational Site | Venlo | |
| Netherlands | Novo Nordisk Investigational Site | Zoetermeer | |
| Puerto Rico | Novo Nordisk Investigational Site | Caguas | |
| Puerto Rico | Novo Nordisk Investigational Site | Manati | |
| Serbia | Novo Nordisk Investigational Site | Belgrade | |
| Serbia | Novo Nordisk Investigational Site | Belgrade | |
| Serbia | Novo Nordisk Investigational Site | Kragujevac | |
| Serbia | Novo Nordisk Investigational Site | Novi Sad | |
| Switzerland | Novo Nordisk Investigational Site | Basel | |
| Switzerland | Novo Nordisk Investigational Site | Genève 14 | |
| Switzerland | Novo Nordisk Investigational Site | Luzern 16 | |
| Switzerland | Novo Nordisk Investigational Site | St. Gallen | |
| Switzerland | Novo Nordisk Investigational Site | Zollikerberg | |
| United Kingdom | Novo Nordisk Investigational Site | Ayr | |
| United Kingdom | Novo Nordisk Investigational Site | Bath | |
| United Kingdom | Novo Nordisk Investigational Site | Bradford-on-Avon | |
| United Kingdom | Novo Nordisk Investigational Site | Haxey | |
| United Kingdom | Novo Nordisk Investigational Site | Headington | |
| United Kingdom | Novo Nordisk Investigational Site | Rotherham | |
| United States | Novo Nordisk Investigational Site | Akron | Ohio |
| United States | Novo Nordisk Investigational Site | Albuquerque | New Mexico |
| United States | Novo Nordisk Investigational Site | Alexandria | Virginia |
| United States | Novo Nordisk Investigational Site | Anniston | Alabama |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Bradenton | Florida |
| United States | Novo Nordisk Investigational Site | Brandon | Florida |
| United States | Novo Nordisk Investigational Site | Burbank | California |
| United States | Novo Nordisk Investigational Site | Carrollton | Texas |
| United States | Novo Nordisk Investigational Site | Charleston | South Carolina |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Colorado Springs | Colorado |
| United States | Novo Nordisk Investigational Site | Colorado Springs | Colorado |
| United States | Novo Nordisk Investigational Site | Coral Gables | Florida |
| United States | Novo Nordisk Investigational Site | Corvallis | Oregon |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Delaware | Ohio |
| United States | Novo Nordisk Investigational Site | Fort Worth | Texas |
| United States | Novo Nordisk Investigational Site | Franklin | Indiana |
| United States | Novo Nordisk Investigational Site | Glendale | Arizona |
| United States | Novo Nordisk Investigational Site | Greenfield | Indiana |
| United States | Novo Nordisk Investigational Site | Greensboro | North Carolina |
| United States | Novo Nordisk Investigational Site | Hawaiian Gardens | California |
| United States | Novo Nordisk Investigational Site | Hialeah | Florida |
| United States | Novo Nordisk Investigational Site | Hickory | North Carolina |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Hyattsville | Maryland |
| United States | Novo Nordisk Investigational Site | Irving | Texas |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Kalamazoo | Michigan |
| United States | Novo Nordisk Investigational Site | Katy | Texas |
| United States | Novo Nordisk Investigational Site | Lansdale | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lomita | California |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
| United States | Novo Nordisk Investigational Site | Madisonville | Kentucky |
| United States | Novo Nordisk Investigational Site | Mesa | Arizona |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami Lakes | Florida |
| United States | Novo Nordisk Investigational Site | Mine Hill | New Jersey |
| United States | Novo Nordisk Investigational Site | Mount Pleasant | South Carolina |
| United States | Novo Nordisk Investigational Site | Muncie | Indiana |
| United States | Novo Nordisk Investigational Site | Murrells Inlet | South Carolina |
| United States | Novo Nordisk Investigational Site | Norristown | Pennsylvania |
| United States | Novo Nordisk Investigational Site | North Massapequa | New York |
| United States | Novo Nordisk Investigational Site | Northridge | California |
| United States | Novo Nordisk Investigational Site | Northridge | California |
| United States | Novo Nordisk Investigational Site | Pell City | Alabama |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Plantation | Florida |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Portland | Oregon |
| United States | Novo Nordisk Investigational Site | Saint Louis | Missouri |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | Savannah | Georgia |
| United States | Novo Nordisk Investigational Site | Spartanburg | South Carolina |
| United States | Novo Nordisk Investigational Site | Sugar Land | Texas |
| United States | Novo Nordisk Investigational Site | Sugar Land | Texas |
| United States | Novo Nordisk Investigational Site | Syracuse | New York |
| United States | Novo Nordisk Investigational Site | Tustin | California |
| United States | Novo Nordisk Investigational Site | West Seneca | New York |
| United States | Novo Nordisk Investigational Site | Whiteville | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Argentina, Croatia, Finland, France, Germany, Greece, Italy, Netherlands, Puerto Rico, Serbia, Switzerland, United Kingdom,
Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical — View Citation
Ahrén B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes O — View Citation
Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jódar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 tri — View Citation
Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15. — View Citation
DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 — View Citation
Fonseca VA, Capehorn MS, Garg SK, Jódar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in insulin resistance are mediated primarily via weight loss in subjects with type 2 diabetes on semaglutide. J Clin Endocrinol Metab. 2019 Apr 2. pii: jc.2018-02685. doi: 10.1210/jc.2018-02685. [Epub ahead of print] — View Citation
Malkin SJP, Russel-Szymczyk M, Liidemann G, Volke V, Hunt B. Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes: A Long-Term Cost-Effectiveness Analysis in Estonia. Diabetes Ther. 2019 Feb;10(1):159-176. doi: 10.100 — View Citation
Overgaard RV, Lindberg SØ, Thielke D. Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23. — View Citation
Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15. — View Citation
Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HBA(1C) =1.0% AND WEIGHT =5.0% WITH SEMAGLUTIDE VS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Mar 13. doi: 10.4158/EP-2018-0444. [Epub ahead of print] — View Citation
Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/d — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Mean change in FPG from baseline to week 56. | Week 0, week 56 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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