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

• Status: Suspended
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• 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:

• DM2 of current diagnosis study inclusion unless not receive drug treatment, with a HbA1c ≥6. 5 and and < 8.5%.

• 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.

Exclusion Criteria:

• 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.