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Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Insulin Mixtard
Metformin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 20 - 35 years.
  2. Gestational age: 20- 36 weeks gestation.
  3. Singleton pregnancy.
  4. Women with pregestational or gestational diabetes mellitus

Exclusion Criteria:

  1. Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
  2. Hypertensive patients.
  3. Women with impaired liver or renal function
  4. Non-compliant patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    oral metformin and insulin

    insulin therapy only

    Arm Description

    Intervention 'Insulin Mixtard' and Intervention 'metformin' had included

    Intervention 'Insulin Mixtard' had included

    Outcomes

    Primary Outcome Measures

    Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
    Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations: 60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus

    Secondary Outcome Measures

    Number of Participants With a Macrosomic Baby
    Fetal macrosomia has been defined birth weight greater than 4500 gm
    Number of Participants With Neonates Who Were Hypoglycemic
    Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery

    Full Information

    First Posted
    March 28, 2017
    Last Updated
    May 19, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03106870
    Brief Title
    Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
    Official Title
    Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.
    Detailed Description
    The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016. All patients were subjected to: History taking: General and Abdominal Examination: With particular emphasis on : Body mass index Blood pressure. Fundal height . Estimated fetal weight . Insulin and metformin doses : Insulin dose: 0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration. Metformin dose : Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day. Investigations: Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women: Group I: pregnant women who received oral metformin in addition to insulin therapy. Group II: pregnant women who received insulin therapy only.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes Mellitus in Pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group I: pregnant women who received oral metformin in addition to insulin therapy. Group II: pregnant women who received insulin therapy only.
    Masking
    Participant
    Masking Description
    Sixty-two opaque envelopes were numbered serially and in each envelope the corresponding letter which detect allocated group were put according to randomization then all envelops were closed and put in one box .When the first patient arrives , the first envelope were opened and the patient were allocated according to the letter inside .
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    oral metformin and insulin
    Arm Type
    Active Comparator
    Arm Description
    Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
    Arm Title
    insulin therapy only
    Arm Type
    Active Comparator
    Arm Description
    Intervention 'Insulin Mixtard' had included
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Mixtard
    Other Intervention Name(s)
    insulin mixtures
    Intervention Description
    Insulin dose: 0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Other Intervention Name(s)
    Metformin Hydrocloride
    Intervention Description
    Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
    Description
    Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations: 60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus
    Time Frame
    from 20 weeks to 36 weeks gestation
    Secondary Outcome Measure Information:
    Title
    Number of Participants With a Macrosomic Baby
    Description
    Fetal macrosomia has been defined birth weight greater than 4500 gm
    Time Frame
    24 hours after delivery
    Title
    Number of Participants With Neonates Who Were Hypoglycemic
    Description
    Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery
    Time Frame
    24 hours after delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 20 - 35 years. Gestational age: 20- 36 weeks gestation. Singleton pregnancy. Women with pregestational or gestational diabetes mellitus Exclusion Criteria: Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy). Hypertensive patients. Women with impaired liver or renal function Non-compliant patients.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

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