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

NCT01572740 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2018-02-07

Study results available
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Summary

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.

Conditions

Interventions

DRUG

liraglutide

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

DRUG

placebo

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

DRUG

insulin

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.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-05
Primary Completion
2012-11-01
Completion
2013-03-27

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01572740 on ClinicalTrials.gov