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

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Rimonabant; Drug: Metformin; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449605

2006-005385-39 (EudraCT Number)

EFC10007

Details and patient eligibility

About

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.

Full description

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

Enrollment: 508 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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508 participants in 2 patient groups

Rimonabant

Experimental group

Description:

Rimonabant 20 mg once daily on top of metformin

Treatment:

Drug: Metformin

Drug: Rimonabant

Glimepiride

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Drug: Glimepiride