Obese Patients With Type 2 Diabetes (RIO-Diabetes)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Non-Insulin-Dependent; Obesity; Obesity in Diabetes

Treatments: Drug: Rimonabant (SR141716)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00029848

EFC4736

Details and patient eligibility

About

To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes

Enrollment: 1,045 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• BMI must be greater than 27 and less than 40
• Treated Type 2 Diabetes on single therapy treatment for at least 1 year
• Stable weight (variation of less than 5 kg within 3 months prior to screening visit)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind