CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 enrolled
Drug / intervention
Semaglutide +1 moredrug
Likely dose
Semaglutide 1.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03086330
NCT03086330Phase 3Completed

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

Novo Nordisk A/S·interventional·Posted Mar 22, 2017·Updated Jul 2, 2021

In Brief

A Phase 3 clinical trial evaluating Semaglutide and Placebo for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 302 participants across 72 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, Japan, Norway, Puerto Rico, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 22, 2017
Enrollment StartMar 15, 2017
Primary CompletionJul 4, 2018
Study CompletionAug 6, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.3 years ago

Interventions

Semaglutidedrug

Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

Placebodrug

Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks