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Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03106870
Recruitment Status : Completed
First Posted : April 11, 2017
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Rehab Mohamed Abdelrahman, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus in Pregnancy Drug: Insulin Mixtard Drug: Metformin Not Applicable

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:

  1. History taking:
  2. General and Abdominal Examination:

    With particular emphasis on :

    • Body mass index
    • Blood pressure.
    • Fundal height .
    • Estimated fetal weight .
  3. 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.

  4. Investigations:

Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:

  1. Group I: pregnant women who received oral metformin in addition to insulin therapy.
  2. Group II: pregnant women who received insulin therapy only.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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 .
Primary Purpose: Treatment
Official Title: Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: oral metformin and insulin
Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Drug: Insulin Mixtard

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.
Other Name: insulin mixtures
Drug: Metformin

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.

Other Name: Metformin Hydrocloride
Active Comparator: insulin therapy only
Intervention 'Insulin Mixtard' had included
Drug: Insulin Mixtard

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.
Other Name: insulin mixtures



Primary Outcome Measures :
  1. Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation [ Time Frame: 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 :
  1. Number of Participants With a Macrosomic Baby [ Time Frame: 24 hours after delivery ]
    Fetal macrosomia has been defined birth weight greater than 4500 gm

  2. Number of Participants With Neonates Who Were Hypoglycemic [ Time Frame: 24 hours after delivery ]
    Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Responsible Party: Rehab Mohamed Abdelrahman, Lecturer of Obstetrics and Gynaecology Faculty of Medicine, Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT03106870     History of Changes
Other Study ID Numbers: Metformin
First Posted: April 11, 2017    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Insulin, pork; isophane insulin, pork drug combination 30:70
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs