NCT00941382

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients

Double-blind, Randomized Clinical Trial to Evaluate Effect of Combination Therapy of Metformin and Sibutramine Versus Metformin or Sibutramine Monotherapy Over Weight, Adiposity, Glucose Metabolism and Inflammatory State in Obese Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effect of sibutramine and metformin combination therapy in comparison with sibutramine or metformin monotherapy over weight, adiposity, glucose metabolism and inflammatory state in obese patients.

Detailed description

The treatment of obesity is strongly recommended because it exacerbates insulin resistance, hypertension, dyslipidemia and atherosclerosis, and represents a risk factor for type 2 diabetes. Although diet and exercise are valuable in this treatment, patient compliance is a major problem. Sibutramine has been shown to be a highly effective pharmacotherapy for weigh loss in obese patients, mediated by increased satiety and an enhancement of energy expenditure. Metformin is widely used for glycemia control and is associated with a small to moderate body weight loss. We are assessing the combination of sibutramine and metformin, two agents with different mechanisms of action for control of body weight and metabolic dysregulation.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Sibutramine-Metformin	sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days
DRUG	Sibutramine	15 mg per day for 180 days
DRUG	Metformin	Metformin 850 mg per day for 180 days

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2009-07-17
• Last updated: 2009-07-17

Locations

1 site across 1 country: Mexico