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

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

Overview[ - collapse ][ - ]

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	Obesity
Intervention	Drug: Sibutramine-Metformin Drug: Sibutramine Drug: Metformin
Phase	Phase 3
Sponsor	Laboratorios Silanes S.A. de C.V.
Responsible Party	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

Tracking Information[ + expand ][ + ]

First Received Date	July 14, 2009
Last Updated Date	July 15, 2009
Start Date	November 2008
Estimated Primary Completion Date	September 2009
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients
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
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 Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Obesity
Intervention	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 therapyDrug: Sibutramine 15 mg per day for 180 days Other Names: Sibutramine monohidrate HydrochlorideDrug: Metformin Metformin 850 mg per day for 180 days Other Names: Metformin Hydrochloride
Study Arm (s)	Experimental: Sibutramin-Metformin Sibutramine-metformin therapy in a single tablet Active Comparator: Sibutramine Sibutramine monotherapy Active Comparator: Metformin Metformin monotherapy

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	60
Estimated Completion Date	September 2009
Estimated Primary Completion Date	August 2009
Eligibility 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
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Mexico

Administrative Information[ + expand ][ + ]

NCT Number	NCT00941382
Other Study ID Numbers	OB Sil-02
Has Data Monitoring Committee	Yes
Information Provided By	Laboratorios Silanes S.A. de C.V.
Study Sponsor	Laboratorios Silanes S.A. de C.V.
Collaborators	Not Provided
Investigators	Study Director: Jorge A González-Canudas, MD Laboratorios SilanesStudy Chair: Manuel González-Ortiz, PHD Universidad de GuadalajaraPrincipal Investigator: ESperanza Martínez-Abundis, PHD Universidad de Guadalajara
Verification Date	July 2009

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