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

Diabetes Mellitus, Type 2 Clinical Trial

— ALLEGRO  

Official title:

A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00449605
• Other study ID #: EFC10007
• Secondary ID: EUDRACT: 2006-00
• Status: Terminated
• Phase: Phase 3
• First received: March 19, 2007
• Last updated: June 12, 2009
• Start date: March 2007
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg od versus glimepiride od in reducing 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 508
• Est. completion date: March 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with legal age

• Body Mass Index >27kg/m2

• Type 2 diabetes as defined by 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• rimonabant (SR141716)
on top of metformin
• glimepiride
on top of metformin

Locations

Country	Name	City	State
Chile	Sanofi-Aventis Administrative Office	Santiago
Chile	Sanofi-aventis adminsitrative office	Santiago
Denmark	Sanofi-Aventis Administrative Office	Horsholm
Finland	Sanofi-Aventis Administrative Office	Helsinki
Hungary	Sanofi-Aventis Administrative Office	Budapest
India	Sanofi-Aventis Administrative Office	Mumbai
Italy	Sanofi-Aventis Administrative Office	Milan
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul
Mexico	Sanofi-Aventis Administrative Office	Mexico
Puerto Rico	Sanofi-Aventis Administrative Office	Puerto Rico
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Spain	Sanofi-Aventis Administrative Office	Barcelona
Sweden	Sanofi-Aventis Administrative Office	Bromma
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Chile,  Denmark,  Finland,  Hungary,  India,  Italy,  Korea, Republic of,  Mexico,  Puerto Rico,  Romania,  Russian Federation,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in glycemic measure HbA1c		52 weeks (1 year)	No
Secondary	Absolute change from baseline in body weight and relative change from baseline in HDL-Cholesterol		1 year	No