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

Sponsor
Novo Nordisk A/S
Study ID
NCT01572740
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 5, 2012
Status verified
Jan 2018
Primary completion
Nov 1, 2012
Completion
Mar 27, 2013

Study Design

Enrollment
257 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lira+Insulin
  • Placebo Comparator: Placebo+Insulin

Primary Outcome Measure

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16 [ Time Frame: Week 0, Week 16 ]

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