Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT00393718
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • liraglutide — DRUG
    0.9 mg/day. Injected s.c. (under the skin) once daily.
  • glibenclamide — DRUG
    1.25-2.5 mg tablet. Given orally once or twice daily.
  • placebo — DRUG
    liraglutide placebo. Injected s.c. (under the skin) once daily.
  • placebo — DRUG
    glibenclamide placebo. Given orally once or twice daily.

Study Details

This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

Key Dates

Start date
Nov 30, 2006
Status verified
Jan 2017
Primary completion
Nov 30, 2007
Completion
May 31, 2008

Study Design

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

Arms

  • Experimental: Liraglutide
    Liraglutide 0.9 mg + glibenclamide placebo
  • Active Comparator: Glibenclamide
    Glibenclamide 1.25-2.5 mg + liraglutide placebo

Primary Outcome Measure

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ]

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