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

NCT ID: NCT00449605

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-03-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rimonabant

Rimonabant 20 mg once daily on top of metformin

Group Type: EXPERIMENTAL

Rimonabant

Intervention Type: DRUG

Tablet, oral administration

Metformin

Intervention Type: DRUG

Metformin continued at stable dose as background therapy

Glimepiride

Glimepiride from 1 mg up to 6 mg once daily on top of metformin

Group Type: ACTIVE_COMPARATOR

Glimepiride

Intervention Type: DRUG

Tablet, oral administration

Metformin

Intervention Type: DRUG

Metformin continued at stable dose as background therapy

Interventions

Rimonabant

Tablet, oral administration

Intervention Type: DRUG

Glimepiride

Tablet, oral administration

Intervention Type: DRUG

Metformin

Metformin continued at stable dose as background therapy

Intervention Type: DRUG

Other Intervention Names

SR141716; Acomplia; HOE490; Amaryl

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ICD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Santiago, , Chile

Sanofi-aventis adminsitrative office

Santiago, , Chile

Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Sanofi-Aventis Administrative Office

Mumbai, , India

Sanofi-Aventis Administrative Office

Milan, , Italy

Sanofi-Aventis Administrative Office

México, , Mexico

Sanofi-Aventis Administrative Office

San Juan, , Puerto Rico

Sanofi-Aventis Administrative Office

Bucharest, , Romania

Sanofi-Aventis Administrative Office

Moscow, , Russia

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Countries

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

Other Identifiers

2006-005385-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC10007

Identifier Type: -

Identifier Source: org_study_id