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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jahan Ara Ainuddin, Dow University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01855763
First received: May 9, 2013
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Gestational Diabetes
Type 2 Diabetes
Pregnancy
Drug: Metformin
Drug: Insulin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metformin in Gestational Diabetes and type2 Diabetes in Pregnancy in a Developing Country

Resource links provided by NLM:


Further study details as provided by Dow University of Health Sciences:

Primary Outcome Measures:
  • Alive baby [ Time Frame: At birth, up to 28 days after birth ] [ Designated as safety issue: Yes ]
    it will include alive , neonatal death and still born

  • Neonatal morbidity [ Time Frame: at birth upto 28 days after birth ] [ Designated as safety issue: Yes ]
    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:
  • glycemic control [ Time Frame: day1 (study entry ) till devlivery ] [ Designated as safety issue: Yes ]

    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


  • weight gain in prenancy [ Time Frame: day 1 (study entry) till delivery ] [ Designated as safety issue: No ]
    total weight gain in pregnancy in kg

  • Maternal hypertensive complications [ Time Frame: day 1(study entry ) till 1 week after delivery ] [ Designated as safety issue: Yes ]
    it will include pregnancy induced hypertension and preeclampsia.


Other Outcome Measures:
  • treatment acceptability and cost of drug [ Time Frame: during study ] [ Designated as safety issue: No ]
    compliance and acceptability of treatment cost of metformin treatment compared with cost of insulin treatment


Enrollment: 300
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • GLUCOPHAGE
  • NEOPHAGE
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855763

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

No publications provided

Responsible Party: Jahan Ara Ainuddin, Associate professor obgyn duhs, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT01855763     History of Changes
Other Study ID Numbers: metformin in gdm & t 2 dm
Study First Received: May 9, 2013
Last Updated: May 13, 2013
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Dow University of Health Sciences:
gestational diabetes
type 2 diabetes
pregnancy
metformin
insulin

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

ClinicalTrials.gov processed this record on November 20, 2014