Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

NCT01512108 · Completed

Last updated 2026-05-28

This clinical trial tested the safety of the medication liraglutide, when added to an existing oral diabetes drug, in adults with type 2 diabetes whose blood sugar was not well controlled by the oral drug alone.

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 363 people

Who can join Ages 20+ · all sexes

Timeline Started 2012-01 · est. completion 2013-04

Where 36 sites · Japan

What this study is testing ClinicalTrials.gov NCT01512108 ↗

Description as written by the study sponsor.

This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.

Treatments tested

liraglutide Drug

0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
oral anti-diabetic drug Drug

An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.

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

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01512108 ↗