Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes (TOCCATA)

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: Placebo (for Rimonabant); Drug: Rimonabant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690456

2007-004833-40 (EudraCT Number)

EFC10518

Details and patient eligibility

About

The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.

Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.

Full description

The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.

Enrollment: 403 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of type 2 diabetes
• HbA1c between 7% to 10% at screening visit
• Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit

Exclusion criteria

• Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
• Weight loss of more than 5 kg within 3 months prior to screening
• Administration of other investigational drugs within 30 days prior to screening visit
• Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant
• Presence or history of cancer within the past five years
• Pregnant or breast-feeding women
• Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.

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

---

403 participants in 2 patient groups, including a placebo group

Rimonabant

Experimental group

Description:

Rimonabant 20 mg once daily on top of metformin

Treatment:

Drug: Rimonabant

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo (for Rimonabant) once daily on top of metformin

Treatment:

Drug: Placebo (for Rimonabant)

Drug: Metformin