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Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes

NCT00690456 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2016-05-18

No results posted yet for this study

Summary

The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.

Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Rimonabant

Tablet, oral administration

DRUG

Placebo (for Rimonabant)

Tablet, oral administration

DRUG

Metformin

Metformin continued at stable dose as background therapy

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States
  • Indonesia
  • Lithuania
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Romania
  • Russia
  • Slovakia
  • Taiwan
  • Thailand
  • Ukraine

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 NCT00690456 on ClinicalTrials.gov