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

• Status: Unknown status
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Metformin; Sibutramine

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