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

NCT00941382 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-07-17

No results posted yet for this study

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

Interventions

DRUG

Sibutramine-Metformin

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

DRUG

Sibutramine

15 mg per day for 180 days

DRUG

Metformin

Metformin 850 mg per day for 180 days

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Jorge A González-Canudas, MD · Laboratorios Silanes

  • Manuel González-Ortiz, PHD · University of Guadalajara

  • ESperanza Martínez-Abundis, PHD · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941382 on ClinicalTrials.gov