Comparison of oral antidiabetic drugs with insulin in the treatment of Gestational Diabetes Mellitus.
A phase three open label Randomized Controlled Trial to compare the efficacy of oral anti-diabetic drugs with insulin in the treatment of GDM
Dr Aisha Syed Wali
154 participants
Jan 18, 2013
Interventional
Conditions
Summary
Our purpose is to compare the efficacy of oral hypoglycemic agents with insulin in treatment of Gestational diabetes in our population. Until now the studies have compared either of Metformin or Glibenclamide with insulin. We will study both the drugs in combination where required. Our hypothesis is that oral hypoglycemic agents (Metformin alone or with Glibenclamide where required ) are as effective as insulin in achieving glycemic control in GDM. Moreover oral agents will be much more cost effective and acceptable to pregnant women of mid-low socioeconomic population of Pakistan.
Eligibility
Inclusion Criteria3
- Women diagnosed as GDM, according to criteria given in the protocol.
- Singleton pregnancy.
- Women who consented for study.
Exclusion Criteria5
- Pre-gestational type 1 and type 2 diabetes mellitus
- Overt diabetes (FBG > or equal to 126 mg/dl, Hb A1C > or equal to 6.5%)
- Gestational age > 33 weeks at the time of recruitment.
- Patients on steroid therapy
- Women not tolerating Oral Glucose Tolerance Test.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Metformin: Women with fasting blood sugar 95-109 mg/dl will be started on 250mg per oral twice daily and women with fasting blood sugar 110 - 125 mg/dl will be started on 500mg per oral twice daily, half to one hour before meal, which will be increased to achieve glycemic targets (i.e. fasting blood sugar <95mg/dl and post meal blood sugar <120 mg/dl) to a maximum dose 850mg thrice daily. Glibenclamide: If glycemic control is not achieved on Metformin alone, Glibenclamide 2.5mg per oral per day will be added and increased till a maximum dose of 20mg per day as required.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612001272886