To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

Sponsor
Novo Nordisk A/S
Study ID
NCT00318461
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • liraglutide — DRUG
    0.6 mg for s.c. (under the skin) injection.
  • metformin — DRUG
    1.5-2.0 g tablets
  • glimepiride — DRUG
    4 mg tablets
  • placebo — DRUG
    Glimepiride placebo 1 mg and 2 mg tablets
  • placebo — DRUG
    Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
  • liraglutide — DRUG
    1.2 mg for s.c. (under the skin) injection
  • liraglutide — DRUG
    1.8 mg for s.c. (under the skin) injection

Study Details

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

Key Dates

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

Study Design

Enrollment
1,091 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lira 0.6 + Met
    Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
  • Experimental: Lira 1.2 + Met
    Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
  • Experimental: Lira 1.8 + Met
    Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day
  • Active Comparator: Met Mono
    Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo
  • Active Comparator: Met + Glim
    Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo

Primary Outcome Measure

Change in Glycosylated A1c (HbA1c) at Week 26 [ Time Frame: week 0, week 26 ]

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