Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT00614120
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    0.6 mg/day, s.c. (under the skin) injection
  • placebo — DRUG
    Glimepiride placebo, capsules
  • liraglutide — DRUG
    1.2 mg/day, s.c. (under the skin) injection
  • liraglutide — DRUG
    1.8 mg/day, s.c. (under the skin) injection
  • glimepiride — DRUG
    Capsules, 4.0 mg/day
  • metformin — DRUG
    Tablets, 1.5-2.0 g/day
  • placebo — DRUG
    Liraglutide placebo, s.c. (under the skin) injection

Study Details

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

Key Dates

Start date
Jan 31, 2008
Status verified
Jan 2017
Primary completion
Feb 28, 2009
Completion
Feb 28, 2009

Study Design

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

Arms

  • Experimental: Lira 0.6 + Met
    Liraglutide 0.6 mg + metformin + glimepiride placebo
  • Experimental: Lira 1.2 + Met
    Liraglutide 1.2 mg + metformin + glimepiride placebo
  • Experimental: Lira 1.8 + Met
    Liraglutide + metformin + glimepiride placebo
  • Experimental: Glim + Met
    Glimepiride 4.0 mg + metformin + liraglutide placebo

Primary Outcome Measure

Change in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 0, week 16 ]

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