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MeDiGes Study: Metformine Use in Gestational Diabetes (FIMMET201501)

Primary Purpose

Diabetes, Gestational, Perinatal Disorder, Puerperal Disorder

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Metformin
Insulin Detemir
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes, Gestational

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-45 years old.
  2. Diagnosis of GD, with fasting glucose <120 mg / dL.
  3. not controlled by diet: fasting capillary blood glucose> 95 mg / dl in at least 2-3 times or 1 hour postprandial >140 mg / dl on, at least 2-3 times a week.
  4. 2nd or 3rd trimesters of pregnancy.
  5. Able to give informed consent.

Exclusion Criteria:

  1. Psychopathological situations that do not guarantee proper adhesion to follow up
  2. 1st trimester of pregnancy
  3. gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin.
  4. Patients who can not attend the scheduled consultation.
  5. Language barrier limiting for understanding treatment settings
  6. Twin pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Metformin

    Insulin Detemir

    Arm Description

    850-2550 mg every 24h.

    Individual doses according to glycemic controls.

    Outcomes

    Primary Outcome Measures

    Metformin benefits
    Change of Weigth
    Good glycemic control
    Change of glycemic levels
    Baby wellness
    Weight

    Secondary Outcome Measures

    Adverse event profile
    Number of adverse events
    Fructosamine as a marker of insulinization
    Concentration of fructosamine
    Satisfaction with the treatment
    Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best)
    IL-6 profile
    IL-6 levels
    IL-10 profile and oxidativge stress as well as in lipid profile
    IL-10 (ultrasensitive PCR) levels
    Leptin profile
    Leptin levels
    Ladiponectin and oxidativge stress as well as in lipid profile
    Ladiponectin levels
    LPS profile
    LPS levels
    LBP profile and oxidativge stress as well as in lipid profile
    LBP levels

    Full Information

    First Posted
    December 3, 2019
    Last Updated
    May 14, 2020
    Sponsor
    Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04222348
    Brief Title
    MeDiGes Study: Metformine Use in Gestational Diabetes
    Acronym
    FIMMET201501
    Official Title
    Efficacy of Metformin Treatment in Not Controlled With Diet Gestational Diabetes Versus Use of Insulin Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 26, 2016 (Actual)
    Primary Completion Date
    May 28, 2020 (Anticipated)
    Study Completion Date
    July 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.
    Detailed Description
    Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly. One: metformin at a dose of 850-2550mg every 24h; two: insulin detemir associated or not with rapid insulin analogue (aspart) according to your glycemic controls. The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy. The objectives are: Demonstrate that treatment with metformin in women with GD (not controlled with diet) can get no lower obstetric and perinatal outcomes than those with standard treatment with insulin. Demonstrate that glycemic control with metformin in properly selected women, can be equivalent to that obtained with insulin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes, Gestational, Perinatal Disorder, Puerperal Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Inferiority, randomized, open, parallel arms, multicenter clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Metformin
    Arm Type
    Experimental
    Arm Description
    850-2550 mg every 24h.
    Arm Title
    Insulin Detemir
    Arm Type
    Active Comparator
    Arm Description
    Individual doses according to glycemic controls.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Description
    850-2550 mg every 24h.
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Detemir
    Intervention Description
    Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
    Primary Outcome Measure Information:
    Title
    Metformin benefits
    Description
    Change of Weigth
    Time Frame
    50 weeks
    Title
    Good glycemic control
    Description
    Change of glycemic levels
    Time Frame
    50 weeks
    Title
    Baby wellness
    Description
    Weight
    Time Frame
    Delivery
    Secondary Outcome Measure Information:
    Title
    Adverse event profile
    Description
    Number of adverse events
    Time Frame
    50 weeks
    Title
    Fructosamine as a marker of insulinization
    Description
    Concentration of fructosamine
    Time Frame
    50 weeks
    Title
    Satisfaction with the treatment
    Description
    Questionnaire of satisfaction with the treatment. Range: 5 (worst)-16 (best)
    Time Frame
    50 weeks
    Title
    IL-6 profile
    Description
    IL-6 levels
    Time Frame
    50 weeks
    Title
    IL-10 profile and oxidativge stress as well as in lipid profile
    Description
    IL-10 (ultrasensitive PCR) levels
    Time Frame
    50 weeks
    Title
    Leptin profile
    Description
    Leptin levels
    Time Frame
    50 weeks
    Title
    Ladiponectin and oxidativge stress as well as in lipid profile
    Description
    Ladiponectin levels
    Time Frame
    50 weeks
    Title
    LPS profile
    Description
    LPS levels
    Time Frame
    50 weeks
    Title
    LBP profile and oxidativge stress as well as in lipid profile
    Description
    LBP levels
    Time Frame
    50 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-45 years old. Diagnosis of GD, with fasting glucose <120 mg / dL. not controlled by diet: fasting capillary blood glucose> 95 mg / dl in at least 2-3 times or 1 hour postprandial >140 mg / dl on, at least 2-3 times a week. 2nd or 3rd trimesters of pregnancy. Able to give informed consent. Exclusion Criteria: Psychopathological situations that do not guarantee proper adhesion to follow up 1st trimester of pregnancy gastrointestinal diseases that may cause poorer tolerance or increased symptoms with metformin. Patients who can not attend the scheduled consultation. Language barrier limiting for understanding treatment settings Twin pregnancy.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    MeDiGes Study: Metformine Use in Gestational Diabetes

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