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

NCT00294723 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2017-03-07

Study results available
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Summary

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).

Conditions

Interventions

DRUG

liraglutide

1.8 mg for s.c. (under the skin) injection

DRUG

glimepiride

8 mg capsule

DRUG

liraglutide

1.2 mg for s.c. (under the skin) injection

DRUG

placebo

Glimepiride placebo, 8mg capsule

DRUG

placebo

Liraglutide placebo, 200 mcl

DRUG

placebo

Liraglutide placebo, 300 mcl

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States
  • Mexico
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294723 on ClinicalTrials.gov