Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

NCT01572740 · Completed

Last updated 2026-05-28

This clinical trial tested whether adding the medication liraglutide to insulin therapy helps lower blood sugar levels in Japanese adults with type 2 diabetes compared to insulin alone.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 257 people

Who can join Ages 20+ · all sexes

Timeline Started 2012-04 · est. completion 2013-03

Where 23 sites · Japan

What this study is testing ClinicalTrials.gov NCT01572740 ↗

Description as written by the study sponsor.

This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.

Treatments tested

liraglutide Drug

Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
placebo Drug

Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
insulin Drug

All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.

Main thing measured	Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01572740 ↗