A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.

Sponsor
Novo Nordisk A/S
Study ID
NCT02505334
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • liraglutide — DRUG
    Injected subcutaneously s.c. (under the skin) once daily.

Study Details

This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.

Key Dates

Start date
Jul 21, 2015
Status verified
Jul 2018
Primary completion
May 2, 2017
Completion
Nov 9, 2017

Study Design

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

Arms

  • Experimental: Liraglutide 1.8 mg
    The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.
  • Active Comparator: Liraglutide 0.9 mg
    The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.

Primary Outcome Measure

Change in Glycosylated Haemoglobin (HbA1c) (Week 26) [ Time Frame: Week 0, Week 26 ]

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