Metformin Treatment in Gestational Diabetes and Noninsulin Dependent Diabetes in Pregnancy in a Developing Country

NCT01855763 | Unknown Phase 2 DMC

• 1 other identifier: metformin in gdm & t 2 dm
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gestational Diabetes; Type 2 Diabetes; Pregnancy

Keywords

gestational diabetes; type 2 diabetes; pregnancy; metformin; insulin

Outcome Measures

Primary Outcomes (2)

• Alive baby

  it will include alive , neonatal death and still born

  At birth, up to 28 days after birth

• Neonatal morbidity

  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.

  at birth upto 28 days after birth

Secondary Outcomes (3)

• glycemic control

  day1 (study entry ) till devlivery

• weight gain in prenancy

  day 1 (study entry) till delivery

• Maternal hypertensive complications

  day 1(study entry ) till 1 week after delivery

Other Outcomes (1)

• treatment acceptability and cost of drug

  during study

Study Arms (2)

metformin

EXPERIMENTAL

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

insulin

ACTIVE COMPARATOR

GroupA2:gestational diabetes on insulin treatment Group B2:type 2 diabetes on insulin treatment intervention:insulin treatment till delivery

Drug: Insulin

Interventions

Metformin DRUG

Also known as: GLUCOPHAGE, NEOPHAGE

metformin

Insulin DRUG

Also known as: humulin insulin

insulin

Eligibility Criteria

• Age: 20 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Related Publications (1)

• Ainuddin JA, Karim N, Zaheer S, Ali SS, Hasan AA. Metformin treatment in type 2 diabetes in pregnancy: an active controlled, parallel-group, randomized, open label study in patients with type 2 diabetes in pregnancy. J Diabetes Res. 2015;2015:325851. doi: 10.1155/2015/325851. Epub 2015 Mar 22.

  PMID: 25874236 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Metformin; Insulin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• jahanara ainuddin, MBBS, FCPS

  Associate Professor Dow university of health sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor obgyn duhs

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 16, 2013
• Study Start: December 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 16, 2013

Record last verified: 2013-05