MedTrace Logo

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

NCT00318461 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1091

Last updated 2017-03-07

Study results available
· View outcomes & findings →

Summary

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).

Conditions

Interventions

DRUG

liraglutide

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

DRUG

metformin

1.5-2.0 g tablets

DRUG

glimepiride

4 mg tablets

DRUG

placebo

Glimepiride placebo 1 mg and 2 mg tablets

DRUG

placebo

Liraglutide placebo 1-3 mL for s.c. (under the skin) injection

DRUG

liraglutide

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

DRUG

liraglutide

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

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
2006-05-31
Primary Completion
2007-05-31
Completion
2008-11-30

Countries

  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Croatia
  • Denmark
  • Germany
  • Hungary
  • India
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • United Kingdom

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 NCT00318461 on ClinicalTrials.gov