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

What Was Tested

The trial (phase 2, phase 3) is built around Insulin (regular human).

It had two arms (groups): metformin (experimental) and insulin (active comparator).

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

The registry classes the interventions as drug.

More on the Plan

A written informed consent was taken from the participants of the study and the consequences and suspected outcomes were informed.

All pregnant women were subjected to screening after evaluation of high risk factors at their first antenatal visit irrespective of gestational age in order to pick undiagnosed type 2 diabetes early in pregnancy.

Women who were screen negative at first antenatal visit were subjected to repeat screening at 24-28 weeks and 32-36 weeks.

A 50gm oral glucose challenge test (GCT) was done as an initial screening test irrespective of the fasting status and a blood sugar level of 140gm/dl was considered as a positive GCT.

Who Took Part

The registry lists 300 actual participants took part.

It was open to women only aged from 20 years up to 46 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-12 with completion listed for 2013-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Alive baby (time frame: At birth, up to 28 days after birth). Neonatal morbidity (time frame: at birth upto 28 days after birth).

It also tracked 3 secondary outcomes, for example glycemic control, weight gain in prenancy and Maternal hypertensive complications.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin (regular human) in 300 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.