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A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes

NCT00449605 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2016-05-16

No results posted yet for this study

Summary

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.

The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Rimonabant

Tablet, oral administration

DRUG

Glimepiride

Tablet, oral administration

DRUG

Metformin

Metformin continued at stable dose as background therapy

Sponsors & Collaborators

Principal Investigators

  • ICD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-11-30
Completion
2009-03-31

Countries

  • United States
  • Chile
  • Denmark
  • Finland
  • Hungary
  • India
  • Italy
  • Mexico
  • Puerto Rico
  • Romania
  • Russia
  • South Korea
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT00449605 on ClinicalTrials.gov