CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 308 enrolled
Drug / intervention
semaglutide +2 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/NCT02254291
NCT02254291Phase 3Completed

Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Oct 1, 2014·Updated Sep 13, 2018

In Brief

A Phase 3 clinical trial evaluating semaglutide and sitagliptin for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 308 participants across 25 sites.

Detailed Summary

This trial is conducted in Japan. The purpose is to compare the safety of once-weekly dosing of semaglutide (0.5 and 1.0 mg) versus sitagliptin (100 mg) once daily, both as monotherapy during 30 weeks of treatment in Japanese subjects with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 1, 2014
Enrollment StartOct 2, 2014
Primary CompletionNov 11, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.8 years ago

Interventions

semaglutidedrug

Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

semaglutidedrug

Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).

sitagliptindrug

Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.