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

July 15, 2009 updated by: Laboratorios Silanes S.A. de C.V.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Centro Universitario de Ciencias de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sibutramin-Metformin
Sibutramine-metformin therapy in a single tablet
Drug: Sibutramine-Metformin
sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days
Other Names:
  • combination therapy
Active Comparator: Sibutramine
Sibutramine monotherapy
Drug: Sibutramine
15 mg per day for 180 days
Other Names:
  • Sibutramine monohidrate Hydrochloride
Active Comparator: Metformin
Metformin monotherapy
Drug: Metformin
Metformin 850 mg per day for 180 days
Other Names:
  • Metformin Hydrochloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratorios Silanes S.A. de C.V.

Investigators

  • Study Director: Jorge A González-Canudas, MD, Laboratorios Silanes
  • Study Chair: Manuel González-Ortiz, PHD, University of Guadalajara
  • Principal Investigator: ESperanza Martínez-Abundis, PHD, University of Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 17, 2009

Study Record Updates

Last Update Posted (Estimate)

July 17, 2009

Last Update Submitted That Met QC Criteria

July 15, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OB Sil-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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