To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
  1.8 mg for s.c. (under the skin) injection
• glimepiride — DRUG
  8 mg capsule
• liraglutide — DRUG
  1.2 mg for s.c. (under the skin) injection
• placebo — DRUG
  Glimepiride placebo, 8mg capsule
• placebo — DRUG
  Liraglutide placebo, 200 mcl
• placebo — DRUG
  Liraglutide placebo, 300 mcl

Study Details

This trial is conducted in North America (the United States of America (USA) and Mexico). The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

Key Dates

Start date

Feb 28, 2006

Status verified

Jan 2017

Primary completion

Nov 30, 2008

Completion

Nov 30, 2008

Study Design

Enrollment

746 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lira 1.8
  Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).
• Experimental: Lira 1.2
  Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).
• Active Comparator: Glimepiride - 1
  Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).
• Active Comparator: Glimepiride - 2
  Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).

Primary Outcome Measure

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 [ Time Frame: week 0, week 52 ]

Locations (102)

Find similar trials in Concord, CA

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