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

Phase 3

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Rimonabant; Drug: Glimepiride; Drug: Metformin

• Registration Number: NCT00449605
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-19
• Study First Posted: 2007-03-20
• Primary Completion: 2008-11
• Study Completion: 2009-03
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-13
• Disposition First Submitted QC: 2016-04-13
• Last Update Submitted: 2016-04-13
• Disposition First Posted: 2016-05-16
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

• Patients with legal age
• Body Mass Index >27kg/m2
• Type 2 diabetes as defined by World Health Organization (WHO) criteria, treated with metformin for at least 6 months and with a stable dose of metformin >=1500 mg/day for at least three months
• HbA1c >=7% and <=9% at screening visit

Exclusion Criteria

• Weight loss > 5 kg within three months prior to screening
• Presence of any clinically significant endocrine disease according to the Investigator
• Presence of type 1 diabetes
• Presence or history of cancer within the past 5 years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer
• Previous participation in a clinical study with rimonabant
• Absence of effective medical contraceptive method for females of childbearing potential
• Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
• Within 2 months prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
• Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study, including uncontrolled serious psychiatric illness

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rimonabant	Rimonabant	Rimonabant 20 mg once daily on top of metformin
Rimonabant	Metformin	Rimonabant 20 mg once daily on top of metformin
Glimepiride	Glimepiride	Glimepiride from 1 mg up to 6 mg once daily on top of metformin
Glimepiride	Metformin	Glimepiride from 1 mg up to 6 mg once daily on top of metformin

Primary Outcome Measures

Name	Time	Method
Change from baseline in glycemic measure HbA1c	52 weeks (1 year)

Secondary Outcome Measures

Name	Time	Method
Absolute change from baseline in body weight	52 weeks
Relative change from baseline in HDL-C	52 weeks

Trial Locations

Locations (2)

Sanofi-aventis adminsitrative office; 🇨🇱 Santiago, Chile

Sanofi-Aventis Administrative Office; 🇸🇪 Bromma, Sweden