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Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug

NCT00478595 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 458

Last updated 2016-06-06

No results posted yet for this study

Summary

The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).

The secondary objectives are:

* To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
* To evaluate the safety and tolerability of Rimonabant compared to placebo;
* To evaluate the pharmacokinetics of Rimonabant.

Conditions

Interventions

DRUG

Rimonabant

Tablet, oral administration

DRUG

Placebo (for Rimonabant)

Tablet, oral administration

DRUG

Anti-diabetic monotherapy

Previous treatment with Sulfonylurea or α-glucosidase inhibitor continued at stable dose during the study period

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT00478595 on ClinicalTrials.gov