CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 868 enrolled
Drug / intervention
Semaglutide 0.5 mg +5 moredrug
Likely dose
Semaglutide 0.5 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/NCT03061214
NCT03061214Phase 3Completed

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes. A 30-week Randomised, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-centre and Multi-national Trial

Novo Nordisk A/S·interventional·Posted Feb 23, 2017·Updated Mar 2, 2021

In Brief

A Phase 3 clinical trial evaluating Semaglutide 0.5 mg, Semaglutide 1.0 mg, and 4 other interventions for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 868 participants across 67 sites in 7 countries.

Detailed Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, China, Hong Kong, South Africa, South Korea, Taiwan, Ukraine
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartAug 28, 2017
Primary CompletionMar 14, 2019
Study CompletionApr 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.4 years ago

Interventions

Semaglutide 0.5 mgdrug

Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks

Semaglutide 1.0 mgdrug

Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks

Sitagliptin placebodrug

Sitagliptin placebo tablets taken once-daily for 30 weeks

Sitagliptindrug

100 mg sitagliptin tablets taken once-daily for 30 weeks

Semaglutide placebo 0.5 mgdrug

Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks

Semaglutide placebo 1.0 mgdrug

Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks