Trials / Completed
CompletedNCT03086330
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 302 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Semaglutide | Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks |
| DRUG | Placebo | Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks |
Timeline
- Start date
- 2017-03-15
- Primary completion
- 2018-07-04
- Completion
- 2018-08-06
- First posted
- 2017-03-22
- Last updated
- 2021-07-02
- Results posted
- 2019-08-20
Locations
72 sites across 7 countries: United States, Austria, Canada, Japan, Norway, Puerto Rico, Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03086330. Inclusion in this directory is not an endorsement.