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

Phase 3

• Conditions: Obesity
• Interventions: Drug: Sibutramine-Metformin; Drug: Sibutramine; Drug: Metformin

• Registration Number: NCT00941382
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

Brief 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.

Study Timeline

• Study Start: 2008-11
• Status Verified: 2009-07
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-15
• Last Update Submitted: 2009-07-15
• Study First Posted: 2009-07-17
• Last Update Posted: 2009-07-17
• Primary Completion: 2009-08
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sibutramin-Metformin	Sibutramine-Metformin	Sibutramine-metformin therapy in a single tablet
Sibutramine	Sibutramine	Sibutramine monotherapy
Metformin	Metformin	Metformin monotherapy

Primary Outcome Measures

Name	Time	Method
improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein	6 months

Secondary Outcome Measures

Name	Time	Method
improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity	6 months
adverse events	6 months

Trial Locations

Locations (1)

Centro Universitario de Ciencias de la Salud; 🇲🇽 Guadalajara, Jalisco, Mexico