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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00941382
• Other study ID #: OB Sil-02
• Status: Unknown status
• Phase: Phase 3
• First received: July 14, 2009
• Last updated: July 15, 2009
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2009
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• 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
• Sibutramine
15 mg per day for 180 days
• Metformin
Metformin 850 mg per day for 180 days

Locations

Country	Name	City	State
Mexico	Centro Universitario de Ciencias de la Salud	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

References & Publications (16)

Bloomgarden ZT. Metformin. Diabetes Care. 1995 Jul;18(7):1078-80. — View Citation

Cachofeiro V. Obesidad, Inflamación y disfunción endotelial. Rev Esp Obes 4: 194-204, 2006.

Campbell I. The obesity epidemic: can we turn the tide? Heart. 2003 May;89 Suppl 2:ii22-4; discussion ii35-7. Review. — View Citation

Clément K, Ferré P. Genetics and the pathophysiology of obesity. Pediatr Res. 2003 May;53(5):721-5. Epub 2003 Mar 5. Review. — View Citation

Ferrannini E, Mari A. How to measure insulin sensitivity. J Hypertens. 1998 Jul;16(7):895-906. Review. — View Citation

Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. — View Citation

González-Ortiz M, Martínez-Abundis E, Mora-Martínez JM, Grover-Páez F. Renal handling of uric acid assessed by means of pharmacological tests in obese women. Diabetes Nutr Metab. 2001 Aug;14(4):189-94. — View Citation

Hensrud DD, Klein S. Extreme obesity: a new medical crisis in the United States. Mayo Clin Proc. 2006 Oct;81(10 Suppl):S5-10. Review. — View Citation

Hundal RS, Inzucchi SE. Metformin: new understandings, new uses. Drugs. 2003;63(18):1879-94. Review. — View Citation

Karnehed N, Rasmussen F, Hemmingsson T, Tynelius P. Obesity and attained education: cohort study of more than 700,000 Swedish men. Obesity (Silver Spring). 2006 Aug;14(8):1421-8. — View Citation

Love-Osborne K, Sheeder J, Zeitler P. Addition of metformin to a lifestyle modification program in adolescents with insulin resistance. J Pediatr. 2008 Jun;152(6):817-22. doi: 10.1016/j.jpeds.2008.01.018. Epub 2008 Mar 19. — View Citation

Lozano Castañeda O. Adipocitoquinas. Rev Endocr Nutr. 10: 147-50, 2002.

Luque CA, Rey JA. The discovery and status of sibutramine as an anti-obesity drug. Eur J Pharmacol. 2002 Apr 12;440(2-3):119-28. Review. — View Citation

Lyle WG; Plastic Surgery Educational Foundation DATA Committee. Pharmacological treatment of obesity. Plast Reconstr Surg. 2002 Nov;110(6):1577-80. — View Citation

McNulty SJ, Ur E, Williams G; Multicenter Sibutramine Study Group. A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. Diabetes Care. 2003 Jan;26(1):125-31. — View Citation

Weigle DS. Pharmacological therapy of obesity: past, present, and future. J Clin Endocrinol Metab. 2003 Jun;88(6):2462-9. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein		6 months
Secondary	improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity		6 months
Secondary	adverse events		6 months