Overview

This trial is active, not recruiting.

Condition obesity
Treatments sibutramine-metformin, sibutramine, metformin
Phase phase 3
Sponsor Laboratorios Silanes S.A. de C.V.
Start date November 2008
End date August 2009
Trial size 60 participants
Trial identifier NCT00941382, OB Sil-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Sibutramine-metformin therapy in a single tablet
sibutramine-metformin combination therapy
sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days
(Active Comparator)
Sibutramine monotherapy
sibutramine Sibutramine monohidrate Hydrochloride
15 mg per day for 180 days
(Active Comparator)
Metformin monotherapy
metformin Metformin Hydrochloride
Metformin 850 mg per day for 180 days

Primary Outcomes

Measure
improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein
time frame: 6 months

Secondary Outcomes

Measure
improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity
time frame: 6 months
adverse events
time frame: 6 months

Eligibility Criteria

Male or female participants from 30 years up to 50 years old.

Inclusion criteria - Age between 30 and 50 years - Both genders - BMI between 30 and 40 - Stable body weigh defined by over 5 per cent variability during the previous 3 months - Fasting serum glucose less than 126 mg per dl - Blood pressure over 140 and 90 mmHg - Women ensuring contraceptive precautions. - Communication and understanding capability. - Informed consent awarding. Exclusion criteria - Women were excluded if they were pregnant or lactating potential while no taking adequate contraceptive precautions - Any smoking during the preceding 6 months - No physical activity, defined by less than 15 minutes per day of walking - Excessive physical activity equivalent to running over 60 minutes per day - Known hypersensitivity to sibutramine or metformin - Low commitment to follow the protocol statements - Any investigational medication during the preceding 6 months - Any drug or substance mayor toxicity exposure during the preceding 3 months - Alcohol or any drug abuse during the previous 3 months - Current medication of oral corticosteroids, anticoagulants, sympathomimetics, sympatholytics, lipid lowering drugs, any medication for type 2 diabetes, and any sibutramine interaction drug - Current or previous evidence of ischemic heart disease, cardiac arrhythmia, cerebrovascular disease, chronic hepatic disease, two fold persistent elevation of ALT, AST or FA - Carrying a pacemaker or any permanent bioelectronic component that could interfere with bioimpedance process - Renal failure defined by serum creatinine equal or ever 1.2 mg per dL - Not controlled thyroid disease defined by altered serum T3, T4 and TSH during the previous 3 months - Hypertension - Type 2 diabetes - Anti-depressants, or any psychiatric disturbance treatment

Additional Information

Official title 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
Principal investigator ESperanza Martínez-Abundis, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Laboratorios Silanes S.A. de C.V..