Fixed Dose Combination of Fluoxetin and Metformin in the Management of Overweight and Obesity

Summary

Clinical trial, multicenter, double-blind, placebo-controlled, comparative of three parallel groups, randomized treatment to assess the efficacy and safety using a fixed dose combination of metformin hydrochloride with fluoxetine as adjunctive treatment in patient with obesity or overweight in order to generate new knowledge and give a greater number of therapeutic options to the clinicians, one group will receive metformin 1700 mg and 40 mg of fluoxetine; Another group will receive metformin 1000 mg with 40 mg of fluoxetine, and a third group called control will receive placebo.

The above described treatments will be administered according to the "Dosage Schedule" The three groups will receive tablets of physical characteristics equal to the reference drug to preserve the blinding.

Conditions

• Overweight and Obesity

Interventions

DRUG

combination metformin hydrochloride/ fluoxetine 500/20 mg

Group A will receive metformin 1000 mg and 40 mg of fluoxetine; after the increment phase. All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition

DRUG

combination metformin hydrochloride/ fluoxetine 1000/20mg

Group B will receive metformin 1700 mg and 40 mg of fluoxetine; after the increment phase. All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition

DRUG

Placebo Oral Tablet

Group C will receive placebo oral tablet; All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition

Sponsors & Collaborators

• INTEC Instituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara.

  collaborator UNKNOWN

• OSMO (OAXACA SITE MANAGEMENT ORGANIZATION, SC)

  collaborator UNKNOWN

• IBIOMED INVESTIGACIÓN BIOMÉDICA PARA EL DESARROLLO DE FÁRMACOS, S.A. DE C.V.

  collaborator UNKNOWN

• Laboratorios Silanes S.A. de C.V.

  lead INDUSTRY

Principal Investigators

• Manuel González, PhD · Instituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Primary Completion

2018-05-31

Completion

2018-11-30

Countries

• Mexico

Study Locations