A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

NCT02254291 · Completed

Last updated 2026-05-28

This clinical trial compares the safety of once-weekly semaglutide to once-daily sitagliptin in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 308 people

Who can join Ages 20+ · all sexes

Timeline Started 2014-10 · est. completion 2015-11

Where 25 sites · Japan

What this study is testing ClinicalTrials.gov NCT02254291 ↗

Description as written by the study sponsor.

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.

Treatments tested

semaglutide Drug

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).
semaglutide Drug

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).
sitagliptin Drug

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

Main thing measured	Number of Treatment Emergent Adverse Events (TEAEs)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02254291 ↗