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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Laboratorios Silanes S.A. de C.V..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00941382
First received: July 14, 2009
Last updated: July 15, 2009
Last verified: July 2009
History of Changes
  Purpose

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 Intervention Phase
Obesity
 Drug: Sibutramine-Metformin
Drug: Sibutramine
Drug: Metformin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941382

Locations
Mexico
Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
Study Director: Jorge A González-Canudas, MD Laboratorios Silanes
Study Chair: Manuel González-Ortiz, PHD Universidad de Guadalajara
Principal Investigator: ESperanza Martínez-Abundis, PHD Universidad de Guadalajara
  More Information

Publications:
Cachofeiro V. Obesidad, Inflamación y disfunción endotelial. Rev Esp Obes 4: 194-204, 2006.
Ferrannini,E. Mari, A. How to mesasure insulin sensitivity. J Hypertens 16: 895-960, 1998.
Lyle W. Pharmacological treatment of obesity. Plastic Rec Surg 110: 1577-80, 2002.
Bloomgarden, Z. Metformin. Diabetes Care 18: 1078-80, 1995.
Campbell I. The obesity epidemic: can we turn the tide? BMJ 22-4, 2003.
Lozano Castañeda O. Adipocitoquinas. Rev Endocr Nutr. 10: 147-50, 2002.

Responsible Party: Jorge González Canudas, Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00941382     History of Changes
Other Study ID Numbers: OB Sil-02
Study First Received: July 14, 2009
Last Updated: July 15, 2009
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Metformin
Sibutramine
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 21, 2013