A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

NCT02207374 · Completed

Last updated 2026-05-28

This clinical trial is testing the safety of semaglutide, taken once a week either alone or with another diabetes medication, in adults in Japan who have 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 601 people

Who can join Ages 20+ · all sexes

Timeline Started 2014-08 · est. completion 2016-02

Where 43 sites · Japan

What this study is testing ClinicalTrials.gov NCT02207374 ↗

Description as written by the study sponsor.

This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy. All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.

Treatments tested

semaglutide Drug

Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.
DPP-4 inhibitor Drug

Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.

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 NCT02207374 ↗