Diabetes Mellitus, Type 2 Clinical Trial
— SUSTAIN™ 4Official title:
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
| 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 Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
| Status | Completed |
| Enrollment | 1089 |
| Est. completion date | September 3, 2015 |
| Est. primary completion date | September 3, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Male or female, 18 years or older at the time of signing informed consent - Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period - Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol - Treatment with any 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 intercurrent illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value greater than or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2 - Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 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 Class IV - Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) - Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novo Nordisk Investigational Site | Buenos Aires | |
| Argentina | Novo Nordisk Investigational Site | Caba | |
| Argentina | Novo Nordisk Investigational Site | Capital Federal | |
| Argentina | Novo Nordisk Investigational Site | Godoy Cruz | |
| Croatia | Novo Nordisk Investigational Site | Cakovec | |
| Croatia | Novo Nordisk Investigational Site | Karlovac | |
| Croatia | Novo Nordisk Investigational Site | Krapinske Toplice | |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| France | Novo Nordisk Investigational Site | Bobigny | |
| France | Novo Nordisk Investigational Site | Bois-Guillaume | |
| France | Novo Nordisk Investigational Site | Bourgoin-jallieu | |
| France | Novo Nordisk Investigational Site | LA ROCHE-sur-YON cedex 9 | |
| France | Novo Nordisk Investigational Site | Le Creusot | |
| France | Novo Nordisk Investigational Site | MARSEILLE Cédex 05 | |
| France | Novo Nordisk Investigational Site | MARSEILLE cedex 08 | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NICE cedex 3 | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Pierre-Bénite | |
| France | Novo Nordisk Investigational Site | Pointe À Pitre | |
| France | Novo Nordisk Investigational Site | Rang-du-fliers | |
| France | Novo Nordisk Investigational Site | Saint Herblain | |
| France | Novo Nordisk Investigational Site | Saint Nazaire | |
| France | Novo Nordisk Investigational Site | Strasbourg | |
| France | Novo Nordisk Investigational Site | Trinité - La Martinique | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Essen | |
| Germany | Novo Nordisk Investigational Site | Jerichow | |
| Germany | Novo Nordisk Investigational Site | Lampertheim | |
| Germany | Novo Nordisk Investigational Site | Ludwigshafen | |
| Germany | Novo Nordisk Investigational Site | Münster | |
| Germany | Novo Nordisk Investigational Site | Neuwied | |
| Germany | Novo Nordisk Investigational Site | Rehlingen-Siersburg | |
| Germany | Novo Nordisk Investigational Site | Rostock | |
| Germany | Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach | |
| Germany | Novo Nordisk Investigational Site | Stuttgart | |
| Germany | Novo Nordisk Investigational Site | Wangen | |
| India | Novo Nordisk Investigational Site | Ahmedabad | Gujarat |
| India | Novo Nordisk Investigational Site | Ahmedabad | Gujarat |
| India | Novo Nordisk Investigational Site | Bangalore | Karnataka |
| India | Novo Nordisk Investigational Site | Chennai | Tamil Nadu |
| India | Novo Nordisk Investigational Site | Indore | Madhya Pradesh |
| India | Novo Nordisk Investigational Site | Kolkata | West Bengal |
| India | Novo Nordisk Investigational Site | Kolkata | |
| India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
| India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
| India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
| India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
| India | Novo Nordisk Investigational Site | Mysore | Karnataka |
| India | Novo Nordisk Investigational Site | Mysore | Karnataka |
| India | Novo Nordisk Investigational Site | New Dehli | New Delhi |
| India | Novo Nordisk Investigational Site | New Delhi | |
| Mexico | Novo Nordisk Investigational Site | Aguascalientes | |
| Mexico | Novo Nordisk Investigational Site | Distrito Federal | México, D.F. |
| Mexico | Novo Nordisk Investigational Site | Guadalajara | Jalisco |
| Mexico | Novo Nordisk Investigational Site | México D.F. | México, D.F. |
| Netherlands | Novo Nordisk Investigational Site | Amsterdam | |
| Netherlands | Novo Nordisk Investigational Site | Hoofddorp | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| North Macedonia | Novo Nordisk Investigational Site | Skopje | |
| North Macedonia | Novo Nordisk Investigational Site | Tetovo | |
| Puerto Rico | Novo Nordisk Investigational Site | Ponce | |
| Romania | Novo Nordisk Investigational Site | Bucharest | |
| Romania | Novo Nordisk Investigational Site | Cluj Napoca | Cluj |
| Romania | Novo Nordisk Investigational Site | Iasi | |
| Romania | Novo Nordisk Investigational Site | Oradea | Bihor |
| Romania | Novo Nordisk Investigational Site | Pitesti | Arges |
| Slovakia | Novo Nordisk Investigational Site | Kosice | |
| Slovakia | Novo Nordisk Investigational Site | Moldava nad Bodvou | |
| Slovakia | Novo Nordisk Investigational Site | Piestany | |
| Slovakia | Novo Nordisk Investigational Site | Puchov | |
| Slovakia | Novo Nordisk Investigational Site | Trencin | |
| Slovenia | Novo Nordisk Investigational Site | Koper | |
| Slovenia | Novo Nordisk Investigational Site | Ljubljana | |
| Slovenia | Novo Nordisk Investigational Site | Novo mesto | |
| South Africa | Novo Nordisk Investigational Site | Cape Town | Western Cape |
| South Africa | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| South Africa | Novo Nordisk Investigational Site | Pretoria | Gauteng |
| United Kingdom | Novo Nordisk Investigational Site | Basingstoke | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Harrogate, North Yorkshire | |
| United Kingdom | Novo Nordisk Investigational Site | Haxey | |
| United Kingdom | Novo Nordisk Investigational Site | Hull | |
| United Kingdom | Novo Nordisk Investigational Site | Ipswich | |
| United Kingdom | Novo Nordisk Investigational Site | Northwood | |
| United Kingdom | Novo Nordisk Investigational Site | Plymouth | |
| United Kingdom | Novo Nordisk Investigational Site | Salford | |
| United Kingdom | Novo Nordisk Investigational Site | Sidcup | |
| United Kingdom | Novo Nordisk Investigational Site | Soham | |
| United Kingdom | Novo Nordisk Investigational Site | Swansea | |
| United Kingdom | Novo Nordisk Investigational Site | Taunton | |
| United States | Novo Nordisk Investigational Site | Albuquerque | New Mexico |
| United States | Novo Nordisk Investigational Site | Altoona | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Amarillo | Texas |
| United States | Novo Nordisk Investigational Site | Anaheim | California |
| United States | Novo Nordisk Investigational Site | Arlington | Virginia |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Avon | Indiana |
| United States | Novo Nordisk Investigational Site | Beaver | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Berlin | New Jersey |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Brooklyn | New York |
| United States | Novo Nordisk Investigational Site | Buckley | Michigan |
| United States | Novo Nordisk Investigational Site | Butte | Montana |
| United States | Novo Nordisk Investigational Site | Canal Fulton | Ohio |
| United States | Novo Nordisk Investigational Site | Carlisle | Ohio |
| United States | Novo Nordisk Investigational Site | Carmichael | California |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chula Vista | California |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Clairton | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Clearwater | Florida |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Colorado Springs | Colorado |
| United States | Novo Nordisk Investigational Site | Conyers | Georgia |
| United States | Novo Nordisk Investigational Site | Cooper City | Florida |
| United States | Novo Nordisk Investigational Site | Corvallis | Oregon |
| United States | Novo Nordisk Investigational Site | Council Bluffs | Iowa |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Elk Grove | California |
| United States | Novo Nordisk Investigational Site | Fargo | North Dakota |
| United States | Novo Nordisk Investigational Site | Flint | Michigan |
| United States | Novo Nordisk Investigational Site | Fort Worth | Texas |
| United States | Novo Nordisk Investigational Site | Gaffney | South Carolina |
| United States | Novo Nordisk Investigational Site | Gilbert | Arizona |
| United States | Novo Nordisk Investigational Site | Greensboro | North Carolina |
| United States | Novo Nordisk Investigational Site | Gurnee | Illinois |
| United States | Novo Nordisk Investigational Site | Hialeah | Florida |
| 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 | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Humble | Texas |
| United States | Novo Nordisk Investigational Site | Hurst | Texas |
| United States | Novo Nordisk Investigational Site | Hyattsville | Maryland |
| United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
| United States | Novo Nordisk Investigational Site | Inglewood | California |
| United States | Novo Nordisk Investigational Site | Irving | Texas |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jersey Shore | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Johns Creek | Georgia |
| United States | Novo Nordisk Investigational Site | Kenosha | Wisconsin |
| United States | Novo Nordisk Investigational Site | Kettering | Ohio |
| United States | Novo Nordisk Investigational Site | Kissimmee | Florida |
| United States | Novo Nordisk Investigational Site | Knoxville | Tennessee |
| United States | Novo Nordisk Investigational Site | La Mesa | California |
| United States | Novo Nordisk Investigational Site | Lake Charles | Louisiana |
| United States | Novo Nordisk Investigational Site | Lakeland | Florida |
| United States | Novo Nordisk Investigational Site | Lansdale | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Long Beach | California |
| United States | Novo Nordisk Investigational Site | Longview | Texas |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Madisonville | Kentucky |
| United States | Novo Nordisk Investigational Site | Marietta | Georgia |
| United States | Novo Nordisk Investigational Site | Marshall | Texas |
| United States | Novo Nordisk Investigational Site | Mason | Ohio |
| United States | Novo Nordisk Investigational Site | Maumee | Ohio |
| United States | Novo Nordisk Investigational Site | Meridian | Idaho |
| United States | Novo Nordisk Investigational Site | Metairie | Louisiana |
| 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 | Morehead City | North Carolina |
| United States | Novo Nordisk Investigational Site | Morganton | North Carolina |
| United States | Novo Nordisk Investigational Site | Murrells Inlet | South Carolina |
| United States | Novo Nordisk Investigational Site | Natchitoches | Louisiana |
| United States | Novo Nordisk Investigational Site | New Windsor | New York |
| United States | Novo Nordisk Investigational Site | Norcross | Georgia |
| United States | Novo Nordisk Investigational Site | Oceanside | California |
| United States | Novo Nordisk Investigational Site | Olympia | Washington |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Ozark | Alabama |
| United States | Novo Nordisk Investigational Site | Paducah | Kentucky |
| United States | Novo Nordisk Investigational Site | Park City | Kansas |
| United States | Novo Nordisk Investigational Site | Peoria | Illinois |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Pomona | California |
| United States | Novo Nordisk Investigational Site | Rapid City | South Dakota |
| United States | Novo Nordisk Investigational Site | Renton | Washington |
| United States | Novo Nordisk Investigational Site | Rialto | California |
| United States | Novo Nordisk Investigational Site | Rolling Hills Estates | California |
| United States | Novo Nordisk Investigational Site | Roseville | California |
| United States | Novo Nordisk Investigational Site | Roswell | Georgia |
| United States | Novo Nordisk Investigational Site | Saint George | Utah |
| United States | Novo Nordisk Investigational Site | Saint Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Saint Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Salt Lake City | Utah |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | San Mateo | California |
| United States | Novo Nordisk Investigational Site | Shelby | North Carolina |
| United States | Novo Nordisk Investigational Site | Sherman Oaks | California |
| United States | Novo Nordisk Investigational Site | Shreveport | Louisiana |
| United States | Novo Nordisk Investigational Site | Spring Hill | Florida |
| United States | Novo Nordisk Investigational Site | Spring Valley | California |
| United States | Novo Nordisk Investigational Site | Statesville | North Carolina |
| United States | Novo Nordisk Investigational Site | Sterling Heights | Michigan |
| United States | Novo Nordisk Investigational Site | Toledo | Ohio |
| United States | Novo Nordisk Investigational Site | Toms River | New Jersey |
| United States | Novo Nordisk Investigational Site | Trenton | New Jersey |
| United States | Novo Nordisk Investigational Site | Troy | Michigan |
| United States | Novo Nordisk Investigational Site | Tuscumbia | Alabama |
| United States | Novo Nordisk Investigational Site | Tustin | California |
| United States | Novo Nordisk Investigational Site | Walnut Creek | California |
| United States | Novo Nordisk Investigational Site | Wenatchee | Washington |
| United States | Novo Nordisk Investigational Site | West Seneca | New York |
| United States | Novo Nordisk Investigational Site | Wilmington | North Carolina |
| United States | Novo Nordisk Investigational Site | Winchester | Virginia |
| United States | Novo Nordisk Investigational Site | Winter Haven | Florida |
| United States | Novo Nordisk Investigational Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Argentina, Croatia, France, Germany, India, Mexico, Netherlands, North Macedonia, Puerto Rico, Romania, Slovakia, Slovenia, South Africa, United Kingdom,
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
Aroda VR, Bain SC, Cariou B, Piletic M, Rose L, Axelsen M, Rowe E, DeVries JH. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 d — 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
Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi — 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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in HbA1c From Baseline | Change in HbA1c from baseline to week 30. | Week 0, week 30 | |
| Secondary | Change in Body Weight From Baseline | Change in body weight from baseline to week 30. | Week 0, week 30 | |
| Secondary | Change in Fasting Plasma Glucose From Baseline | Change in fasting plasma glucose from baseline to week 30. | Week 0, week 30 | |
| Secondary | Change in Diastolic Blood Pressure. | Change in diastolic blood pressure from baseline to week 30. | Week 0, week 30 | |
| Secondary | Change in Systolic Blood Pressure. | Change in systolic blood pressure from baseline to week 30. | Week 0, week 30 | |
| Secondary | Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ | The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30. | Week 0, week 30 | |
| Secondary | Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) | The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured 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. The values displayed are the estimated mean change from baseline to week 30. | Week 0, week 30 | |
| Secondary | Subjects Who Achieve HbA1c =6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) | Subjects who achieve HbA1c =6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment | After 30 weeks treatment |
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