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

Laboratorios Silanes

Status and phase: Unknown; Phase 3

Conditions: Obesity

Treatments: Drug: Sibutramine; Drug: Metformin; Drug: Sibutramine-Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941382

OB Sil-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Sibutramin-Metformin

Experimental group

Description:

Sibutramine-metformin therapy in a single tablet

Treatment:

Drug: Sibutramine-Metformin

Sibutramine

Active Comparator group

Description:

Sibutramine monotherapy

Treatment:

Drug: Sibutramine

Metformin

Active Comparator group

Description:

Metformin monotherapy

Treatment:

Drug: Metformin