Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

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

Insulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery.

The registry classes the interventions as drug.

More on the Plan

75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients.

They were randomised to metformin or insulin group.

If blood sugar levels were not controlled, insulin was added.

The insulin group was given 3 injections of regular insulin \& one intermediate acting insulin injection at night subcutaneously.

Who Took Part

278 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: All pregnant Diagnosed GDM in pregnancy by OGTT from 22 week to 34 week with singleton pregnancy.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: patients with known diabetes mellitus; patients with multiple pregnancy; with essential hypertension or pre eclampsia.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2016-02-01 with completion listed for 2017-06-30.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): maternal glycemic control (time frame: From time of randomisation till 40 weeks).

It also tracked 6 secondary outcomes, for example Fetal macrosomia, Apgar score, Neonatal intensive care unit (NICU) stay, mode of delivery and Neonatal hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 278 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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