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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02305381
Other study ID # NN9535-3627
Secondary ID 2013-004502-26U1
Status Completed
Phase Phase 3
First received
Last updated
Start date December 1, 2014
Est. completion date November 21, 2015

Study information

Verified date May 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate 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.


Recruitment information / eligibility

Status Completed
Enrollment 397
Est. completion date November 21, 2015
Est. primary completion date November 21, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female, age at least 18 years at the time of signing inform consent. For Japan: Male or female, age at least 20 years at the time of signing informed consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin) 7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. Japan: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents 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 bolus insulin in connection with intercurrent illness - Experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness - History of pancreatitis (acute or chronic) - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome 2 (MEN 2) - Severe renal impairment defined as eGFR (estimated glomerular filtration rate) below 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 (NYHA) Class IV

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
semaglutide
Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
placebo
Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Locations

Country Name City State
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Falkensee
Germany Novo Nordisk Investigational Site Friedrichsthal
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hohenmölsen
Germany Novo Nordisk Investigational Site Münster
Germany Novo Nordisk Investigational Site Rehlingen-Siersburg
Germany Novo Nordisk Investigational Site Saint Ingbert-Oberwürzbach
Germany Novo Nordisk Investigational Site Stuttgart
Germany Novo Nordisk Investigational Site Sulzbach-Rosenberg
Japan Novo Nordisk Investigational Site Ibaraki
Japan Novo Nordisk Investigational Site Kashiwara-shi, Osaka
Japan Novo Nordisk Investigational Site Kumamoto-shi, Kumamoto
Japan Novo Nordisk Investigational Site Miyazaki
Japan Novo Nordisk Investigational Site Osaka
Japan Novo Nordisk Investigational Site Tokyo
Puerto Rico Novo Nordisk Investigational Site Manati
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Kragujevac
Serbia Novo Nordisk Investigational Site Novi Sad
Slovakia Novo Nordisk Investigational Site Bratislava
Slovakia Novo Nordisk Investigational Site Kosice
Slovakia Novo Nordisk Investigational Site Levice
Slovakia Novo Nordisk Investigational Site Lucenec
Slovakia Novo Nordisk Investigational Site Presov
United States Novo Nordisk Investigational Site Albuquerque New Mexico
United States Novo Nordisk Investigational Site Amarillo Texas
United States Novo Nordisk Investigational Site Anaheim California
United States Novo Nordisk Investigational Site Ann Arbor Michigan
United States Novo Nordisk Investigational Site Athens Tennessee
United States Novo Nordisk Investigational Site Avon Indiana
United States Novo Nordisk Investigational Site Bountiful Utah
United States Novo Nordisk Investigational Site Bradenton Florida
United States Novo Nordisk Investigational Site Bristol Tennessee
United States Novo Nordisk Investigational Site Chattanooga Tennessee
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chicago Illinois
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 Council Bluffs Iowa
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Dayton Ohio
United States Novo Nordisk Investigational Site Fleming Island Florida
United States Novo Nordisk Investigational Site Flint Michigan
United States Novo Nordisk Investigational Site Fort Worth Texas
United States Novo Nordisk Investigational Site Fresno California
United States Novo Nordisk Investigational Site Gillespie Illinois
United States Novo Nordisk Investigational Site Greenfield Indiana
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Hurst Texas
United States Novo Nordisk Investigational Site Indianapolis Indiana
United States Novo Nordisk Investigational Site Jackson Mississippi
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 Kenosha Wisconsin
United States Novo Nordisk Investigational Site Kettering Ohio
United States Novo Nordisk Investigational Site Kingsport Tennessee
United States Novo Nordisk Investigational Site Las Vegas Nevada
United States Novo Nordisk Investigational Site Las Vegas Nevada
United States Novo Nordisk Investigational Site Levittown Pennsylvania
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Lomita California
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Mesquite Texas
United States Novo Nordisk Investigational Site Metairie Louisiana
United States Novo Nordisk Investigational Site Muncie Indiana
United States Novo Nordisk Investigational Site Northridge California
United States Novo Nordisk Investigational Site Oklahoma City Oklahoma
United States Novo Nordisk Investigational Site Overland Park Kansas
United States Novo Nordisk Investigational Site Paducah Kentucky
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Port Charlotte Florida
United States Novo Nordisk Investigational Site Poway California
United States Novo Nordisk Investigational Site Richmond Virginia
United States Novo Nordisk Investigational Site Riverside California
United States Novo Nordisk Investigational Site Rockville Maryland
United States Novo Nordisk Investigational Site Roseville California
United States Novo Nordisk Investigational Site Roswell Georgia
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Ramon California
United States Novo Nordisk Investigational Site Skokie Illinois
United States Novo Nordisk Investigational Site Spring Hill Florida
United States Novo Nordisk Investigational Site Sugar Land Texas
United States Novo Nordisk Investigational Site Sugar Land Texas
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Teaneck New Jersey
United States Novo Nordisk Investigational Site Topeka Kansas
United States Novo Nordisk Investigational Site Van Nuys California
United States Novo Nordisk Investigational Site Walnut Creek California
United States Novo Nordisk Investigational Site Waltham Massachusetts
United States Novo Nordisk Investigational Site Waterbury Connecticut
United States Novo Nordisk Investigational Site West Seneca New York
United States Novo Nordisk Investigational Site Yukon Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Germany,  Japan,  Puerto Rico,  Serbia,  Slovakia, 

References & Publications (7)

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

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

Rodbard H, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu P-L, Wijayasinghe N, Norwood P. Efficacy and safety of semaglutide once-weekly vs placebo as add-on to basal insulin alone or in combination with metformin in subjects with type

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

Rodbard HW, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu PL, Wijayasinghe N, Norwood P. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. J Clin Endocrinol Metab. 2018 Jun 1;103(6):2291 — 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

Outcome

Type Measure Description Time frame Safety issue
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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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