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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001272886

Enrollment

154

Registered

2012-12-07

Start date

2013-01-18

Completion date

2014-05-09

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 da

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

Women diagnosed as GDM, according to criteria given in the protocol. Singleton pregnancy. Women who consented for study.

Exclusion criteria

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.

Outcome results