Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country (migdm&t2dm)

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. Identifier: NCT01855763
Recruitment Status : Unknown
Verified May 2013 by Jahan Ara Ainuddin, Dow University of Health Sciences.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Information provided by (Responsible Party):
Jahan Ara Ainuddin, Dow University of Health Sciences

Brief Summary:
The study hypothesis was In women with gestational diabetes and type 2 diabetes in pregnancy metformin treatment compared with insulin will result in better perinatal and maternal outcome and improved treatment acceptability with low or noadditional insulin requirement.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Type 2 Diabetes Pregnancy Drug: Metformin Drug: Insulin Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin in Gestational Diabetes and type2 Diabetes in Pregnancy in a Developing Country
Study Start Date : December 2008
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: metformin
group A1:Consists of patients with GDM who were given drug metformin as treatment group B1:Consists of patients with type 2 diabetes in pregnancy were given the drug metformin as treatment intervention with drug metformin is given for control of diabetes in esclation dose of 500mg /day upto 2.5 grams per day in two to three divided doses till delivery
Drug: Metformin
Other Names:

Active Comparator: insulin
GroupA2:gestational diabetes on insulin treatment Group B2:type 2 diabetes on insulin treatment intervention:insulin treatment till delivery
Drug: Insulin
Other Name: humulin insulin

Primary Outcome Measures :
  1. Alive baby [ Time Frame: At birth, up to 28 days after birth ]
    it will include alive , neonatal death and still born

  2. Neonatal morbidity [ Time Frame: at birth upto 28 days after birth ]
    it will include birth weight, macrosomia,neonatal hypoglycemia,transient tachypnoea of newborn ,respiratory distress syndrome,neonatal intensive care admissions, prematurity,sepsis,neonatal jaundice,birth trauma.

Secondary Outcome Measures :
  1. glycemic control [ Time Frame: day1 (study entry ) till devlivery ]

    fasting and random blood glucose levels , at study entry ,mean levels throughout pregnancy and at 36/37 weeks of pregnancy.

    HbA1 C Levels,at study entry and at 36/37 weeks of pregnancy

  2. weight gain in prenancy [ Time Frame: day 1 (study entry) till delivery ]
    total weight gain in pregnancy in kg

  3. Maternal hypertensive complications [ Time Frame: day 1(study entry ) till 1 week after delivery ]
    it will include pregnancy induced hypertension and preeclampsia.

Other Outcome Measures:
  1. treatment acceptability and cost of drug [ Time Frame: during study ]
    compliance and acceptability of treatment cost of metformin treatment compared with cost of insulin treatment

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Ages Eligible for Study:   20 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  1. Pregnancies in women with pre-pregnancy diagnosis of NIDDM (Type 2 DM) and pregnancy continued beyond the first trimester.
  2. Women with gestational diabetes mellitus who are at 20-34 weeks of gestation.
  3. Women who have glucose elevations consistent with undiagnosed diabetes in pregnancy.
  4. Women with impaired glucose tolerance (IGT) at any gestational age of pregnancy and pregnancy continued beyond first trimester.
  5. Singleton pregnancy.

Exclusion Criteria:

  1. Women who have contraindication for metformin intake.
  2. A recognized fetal anomaly at 14-16 weeks ultrasound examination at the time of study entry.
  3. Ruptured membranes at time of study entry.
  4. Women with IDDM (Type 1 DM) entering pregnancy.
  5. Presence of any other medical disorder like essential hypertension, renal disease, hepatic disease, hypothyroidism, cardiac disease.
  6. Presence of diabetic complications.
  7. Patient already on Sulphonylureas.
  8. Multiple pregnancy.
  9. Gestational diabetes controlled on diet alone.

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 identifier (NCT number): NCT01855763

Sponsors and Collaborators
Dow University of Health Sciences
Principal Investigator: jahanara ainuddin, MBBS, FCPS Associate Professor Dow university of health sciences

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jahan Ara Ainuddin, Associate professor obgyn duhs, Dow University of Health Sciences Identifier: NCT01855763     History of Changes
Other Study ID Numbers: metformin in gdm & t 2 dm
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013

Keywords provided by Jahan Ara Ainuddin, Dow University of Health Sciences:
gestational diabetes
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs