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

NCT00941382 | Unknown Phase 3 DMC

• 1 other identifier: OB Sil-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

sibutramine; metformin; obesity

Outcome Measures

Primary Outcomes (1)

• improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein

  6 months

Secondary Outcomes (2)

• improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity

  6 months

• adverse events

  6 months

Study Arms (3)

Sibutramin-Metformin

EXPERIMENTAL

Sibutramine-metformin therapy in a single tablet

Drug: Sibutramine-Metformin

Sibutramine

ACTIVE COMPARATOR

Sibutramine monotherapy

Drug: Sibutramine

Metformin

ACTIVE COMPARATOR

Metformin monotherapy

Drug: Metformin

Interventions

Sibutramine-Metformin DRUG

sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days

Also known as: combination therapy

Sibutramin-Metformin

Sibutramine DRUG

15 mg per day for 180 days

Also known as: Sibutramine monohidrate Hydrochloride

Sibutramine

Metformin DRUG

Metformin 850 mg per day for 180 days

Also known as: Metformin Hydrochloride

Metformin

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Centro Universitario de Ciencias de la Salud

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (16)

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

  BACKGROUND

• Ferrannini E, Mari A. How to measure insulin sensitivity. J Hypertens. 1998 Jul;16(7):895-906. doi: 10.1097/00004872-199816070-00001.

  PMID: 9794728 BACKGROUND

• Lyle WG; Plastic Surgery Educational Foundation DATA Committee. Pharmacological treatment of obesity. Plast Reconstr Surg. 2002 Nov;110(6):1577-80. doi: 10.1097/01.PRS.0000028331.84171.86. No abstract available.

  PMID: 12409783 BACKGROUND

• 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. doi: 10.1016/s0014-2999(02)01423-1.

  PMID: 12007530 BACKGROUND

• Weigle DS. Pharmacological therapy of obesity: past, present, and future. J Clin Endocrinol Metab. 2003 Jun;88(6):2462-9. doi: 10.1210/jc.2003-030151. No abstract available.

  PMID: 12788841 BACKGROUND

• Hundal RS, Inzucchi SE. Metformin: new understandings, new uses. Drugs. 2003;63(18):1879-94. doi: 10.2165/00003495-200363180-00001.

  PMID: 12930161 BACKGROUND

• Bloomgarden ZT. Metformin. Diabetes Care. 1995 Jul;18(7):1078-80. doi: 10.2337/diacare.18.7.1078. No abstract available.

  PMID: 7555549 BACKGROUND

• Campbell I. The obesity epidemic: can we turn the tide? Heart. 2003 May;89 Suppl 2(Suppl 2):ii22-4; discussion ii35-7. doi: 10.1136/heart.89.suppl_2.ii22.

  PMID: 12695431 BACKGROUND

• 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. doi: 10.2337/diacare.26.1.125.

  PMID: 12502668 BACKGROUND

• 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.

  PMID: 18492523 BACKGROUND

• Gonzalez-Ortiz M, Martinez-Abundis E, Mora-Martinez JM, Grover-Paez F. Renal handling of uric acid assessed by means of pharmacological tests in obese women. Diabetes Nutr Metab. 2001 Aug;14(4):189-94.

  PMID: 11716287 BACKGROUND

• Clement K, Ferre P. Genetics and the pathophysiology of obesity. Pediatr Res. 2003 May;53(5):721-5. doi: 10.1203/01.PDR.0000059753.61905.58. Epub 2003 Mar 5.

  PMID: 12621112 BACKGROUND

• 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. doi: 10.1001/jama.288.14.1723.

  PMID: 12365955 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1038/oby.2006.161.

  PMID: 16988085 BACKGROUND

• Hensrud DD, Klein S. Extreme obesity: a new medical crisis in the United States. Mayo Clin Proc. 2006 Oct;81(10 Suppl):S5-10. doi: 10.1016/s0025-6196(11)61175-0.

  PMID: 17036573 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Combined Modality Therapy; sibutramine; Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jorge A González-Canudas, MD

  Laboratorios Silanes

  STUDY DIRECTOR

• Manuel González-Ortiz, PHD

  University of Guadalajara

  STUDY CHAIR

• ESperanza Martínez-Abundis, PHD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 17, 2009
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 17, 2009

Record last verified: 2009-07

Locations

ME (1)