Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT00395746
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • sulfonylurea — DRUG
    SU agent
  • liraglutide — DRUG
    Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.
  • liraglutide — DRUG
    Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.

Study Details

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

Key Dates

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

Study Design

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

Arms

  • Experimental: 0.6 mg + SU
    Liraglutide 0.6 mg + sulphonylurea
  • Experimental: 0.9 mg + SU
    Liraglutide 0.9 mg + sulphonylurea
  • Placebo Comparator: SU Mono - 1
    Liraglutide placebo 0.6 mg + sulphonylurea
  • Placebo Comparator: SU Mono - 2
    Liraglutide placebo 0.9 mg + sulphonylurea

Primary Outcome Measure

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

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