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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00941382
Recruitment Status : Unknown
Verified July 2009 by Laboratorios Silanes S.A. de C.V..
Recruitment status was:  Active, not recruiting
First Posted : July 17, 2009
Last Update Posted : July 17, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Sibutramine-Metformin Drug: Sibutramine Drug: Metformin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

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 Name: combination therapy

Active Comparator: Sibutramine
Sibutramine monotherapy
Drug: Sibutramine
15 mg per day for 180 days
Other Name: Sibutramine monohidrate Hydrochloride

Active Comparator: Metformin
Metformin monotherapy
Drug: Metformin
Metformin 850 mg per day for 180 days
Other Name: Metformin Hydrochloride

Primary Outcome Measures :
  1. improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity [ Time Frame: 6 months ]
  2. adverse events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00941382

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Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
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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

Cachofeiro V. Obesidad, Inflamación y disfunción endotelial. Rev Esp Obes 4: 194-204, 2006.
Lozano Castañeda O. Adipocitoquinas. Rev Endocr Nutr. 10: 147-50, 2002.

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Responsible Party: Jorge González Canudas, Laboratorios Silanes S.A. de C.V. Identifier: NCT00941382     History of Changes
Other Study ID Numbers: OB Sil-02
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: July 17, 2009
Last Verified: July 2009

Keywords provided by Laboratorios Silanes S.A. de C.V.:

Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents