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

NCT03051451 | Suspended Phase 2

• 1 other identifier: 30050/II/16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hydrochloride of Metformin / Fluoxetine; Placebo; Obesity

Outcome Measures

Primary Outcomes (1)

• Decrease of at least 5% of body weight and the reduction in the body mass index.

  Compare BMI after 6 months of treatment with hydrochloride of metformin / fluoxetine. In two doses (1000/40 mg) and (1700/40 mg) or placebo.

  six months

Secondary Outcomes (10)

• Body weight

  six months

• Height

  six months

• Body Mass Index

  six months

• Waist-hip index (hip circumference)

  six months

• Blood pressure measurement

  six months

Study Arms (3)

combination metformin hydrochloride/ fluoxetine 500/20 mg

ACTIVE COMPARATOR

Dosage: The dose will depend on the period of treatment in which the patient is: * Single dose treatment (from visit 2 (from day 0 to day 30 ± 7), the patient will take 1 metformin hydrochloride tablet 500 mg / fluoxetine 20 mg and 1 placebo tablet , every 24 hours in the morning for 30 days). * Treatment at double dose (from visit 3 and until visit 8), the patient will take 2 tablets of metformin hydrochloride 500 mg / fluoxetine 20 mg and 2 tablets of Placebo, every 24 hours in the morning for 150 days).

Drug: combination metformin hydrochloride/ fluoxetine 500/20 mg

combination metformin hydrochloride/ fluoxetine 1000/20mg

ACTIVE COMPARATOR

Dosage: The dose will depend on the period of treatment in which the patient is: * Single dose treatment (from visit 2 (from day 0 to day 30 ± 7), the patient will take 1 metformin hydrochloride tablet 850 mg / fluoxetine 20 mg and 1 placebo tablet , every 24 hours in the morning for 30 days). * Treatment at double dose (from visit 3 and until visit 8), the patient will take 2 tablets of metformin hydrochloride 850 mg / fluoxetine 20 mg and 2 tablets of Placebo, every 24 hours in the morning for 150 days).

Drug: combination metformin hydrochloride/ fluoxetine 1000/20mg

Placebo Oral Tablet

PLACEBO COMPARATOR

Placebo

Drug: Placebo Oral Tablet

Interventions

combination metformin hydrochloride/ fluoxetine 500/20 mg DRUG

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

combination metformin hydrochloride/ fluoxetine 500/20 mg

combination metformin hydrochloride/ fluoxetine 1000/20mg DRUG

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

combination metformin hydrochloride/ fluoxetine 1000/20mg

Placebo Oral Tablet DRUG

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

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of consent informed
• Men and Women.
• ≥ 18 years old proven through a current official identification.
• BMI ≥ 30 kg/m2 with or without Comorbidities.
• BMI ≥ 27 kg/m2 with a diagnosis of comorbidities by patient's clinical record associated with overweight (DM2's recent diagnosis without treatment, hypertension, dyslipidemia, sleep apnea or secondary heart disease) defined as follows:
• Arterial Systemic Hypertension with figures \< 140 / 90 mmHg.
• Dyslipidemia with total cholesterol levels\> 200 mg / dl and \<240 mg / dl, and / or LDL-C\> 100 and \<160 mg / dl and / or triglycerides\> 150 mg / dl and \<400 mg / dl.
• In case of have drug treatment for hypertension or dyslipidemia, the participants must have a stable dose for at least 3 months prior to the elective visit.
• Women in childbearing age must use a reliable method of birth control, such as barrier methods (condom, diaphragm), fallopian tube obstruction, intrauterine device.

You may not qualify if:

• Endogenous obesity (endocrine diseases that condition gain of weight, such as hypothyroidism, syndrome of Cushing).
• Background of patient's clinical record history of iatrogenic obesity (use of drugs that determine weight gain, such as corticosteroids, antipsychotic and antiepileptic).
• Thyroid stimulating Hormone (TSH) is out of range.
• Prolongation of the QT interval corrected for rate (QTc) segment by electrocardiogram with the formula of prolonged Bazett (greater than 450 msec. in males and 470 msec in women).
• Creatinine ≥1. 3 mg/dl in women and ≥1. 5 mg/dl in men.
• Alanine transaminase(ALT) or Aspartate Aminotransferase (AST) \> 2 times above from the normal value.
• Background of patient's clinical record of depressive disorder or anxiety that - may require therapy with psychiatric drugs.
• Intolerance known to drugs in the study.
• Pregnancy or breastfeeding.
• Use of medications, supplements or other techniques whose objective is the reduction of weight.
• Use of medications contraindicated with drugs study.

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead
• INTEC Instituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara.: collaborator
• OSMO (OAXACA SITE MANAGEMENT ORGANIZATION, SC): collaborator
• IBIOMED INVESTIGACIÓN BIOMÉDICA PARA EL DESARROLLO DE FÁRMACOS, S.A. DE C.V.: collaborator

Study Sites (1)

Laboratorios SIlanes S.A. de C.V,

Mexico City, Mexico City, 03100, Mexico

Location

Related Links

• Efficacy and safety using fluoxetin

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Manuel González, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: February 13, 2017
• Primary Completion: May 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)