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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051451
Recruitment Status : Suspended (Business decision)
First Posted : February 13, 2017
Last Update Posted : September 1, 2017
Sponsor:
Collaborators:
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)
IBIOMED INVESTIGACIÓN BIOMÉDICA PARA EL DESARROLLO DE FÁRMACOS, S.A. DE C.V.
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.

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.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Drug: combination metformin hydrochloride/ fluoxetine 500/20 mg Drug: combination metformin hydrochloride/ fluoxetine 1000/20mg Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy of Two Fixed Dose Combination of Metformin/Fluoxetin 1000/40 mg vs. 1700/40 mg in the Management of Overweight and Obesity
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: combination metformin hydrochloride/ fluoxetine 500/20 mg

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

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


Active Comparator: combination metformin hydrochloride/ fluoxetine 1000/20mg

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

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


Placebo Comparator: Placebo Oral Tablet
Placebo
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




Primary Outcome Measures :
  1. Decrease of at least 5% of body weight and the reduction in the body mass index. [ Time Frame: six months ]
    Compare BMI after 6 months of treatment with hydrochloride of metformin / fluoxetine. In two doses (1000/40 mg) and (1700/40 mg) or placebo.


Secondary Outcome Measures :
  1. Body weight [ Time Frame: six months ]
    the mass of the body in kilograms

  2. Height [ Time Frame: six months ]
    expressed in meters

  3. Body Mass Index [ Time Frame: six months ]
    relationship between weight and height, used to classify underweight, overweight and obesity, calculated by dividing the weight in kilograms by the square of the height in meters

  4. Waist-hip index (hip circumference) [ Time Frame: six months ]
    The waist hip index will be obtained by measuring the waist perimeter in centimeters at the last floating rib level and the maximum hip perimeter at the gluteal level.

  5. Blood pressure measurement [ Time Frame: six months ]
    The blood pressure measurement will be performed with a calibrated and verified sphygmomanometer in mm/Hg

  6. Fasting glucose concentration [ Time Frame: six months ]
    Glucose concentrations in mg/dl from blood serum will be determined in patients in fasting condition

  7. Insulin levels [ Time Frame: six months ]
    Serum insulin levels in µl/ml will be quantified using an enzyme immunoassay technique

  8. concentrations of lipid profile [ Time Frame: six months ]
    Percentage of reduction of cholesterol levels in mg/dl after 6 months of treatment.

  9. fat mass [ Time Frame: six months ]
    Measured by bioimpedance

  10. concentrations of lipid profile [ Time Frame: six months ]
    Percentage of reduction LDL-C and / or triglycerides in mg/dl after 6 months of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051451


Locations
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Mexico
Laboratorios SIlanes S.A. de C.V,
Mexico Distrito Federal, Mexico City, Mexico, 03100
Sponsors and Collaborators
Laboratorios Silanes 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)
IBIOMED INVESTIGACIÓN BIOMÉDICA PARA EL DESARROLLO DE FÁRMACOS, S.A. DE C.V.
Investigators
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Principal Investigator: Manuel González, PhD Instituto de Terapéutica Experimental y Clínica, Departamento de Fisiología, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara.
Additional Information:
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Responsible Party: Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier: NCT03051451    
Other Study ID Numbers: 30050/II/16
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Silanes S.A. de C.V.:
Hydrochloride of Metformin / Fluoxetine
Placebo
Obesity
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Metformin
Fluoxetine
Hypoglycemic Agents
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors