Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.

It had two arms (groups): Insulin Group (active comparator) and Metformin Group (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 124 actual participants took part.

It was open to women only aged from 19 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients aged (19-35) years. BMI 18-30 kg/m2. Gestational age \>24 weeks.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: pregnant women with preexisting diabetes mellitus; women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis); patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, sle etc).

How the Study Was Run

Design: 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.

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 2018-02-01 with completion listed for 2018-12-25.

It ran at 1 site in Egypt.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Rate of maternal weight gain per week (time frame: 4 months).

It also tracked 5 secondary outcomes, for example 1-min APGAR score, 5-min APGAR score, Incidence of neonatal hypoglycemia, Incidence of neonatal respiratory distress and Incidence of macrosomia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 124 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.