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

Launched by LABORATORIOS SILANES S.A. DE C.V. · Jul 15, 2009

Keywords

ClinConnect Summary

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 combina...

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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