Metformin Versus Insulin in Gestational Diabetes

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

Gestational diabetes is traditionally treated with insulin.

Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes.

The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes.

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

NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values.

The registry classes the interventions as drug.

More on the Plan

The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.

Who Took Part

Enrollment: 221 actual participants took part.

It was open to women only.

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

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: renal, hepatic or cardiac failure; pregestational use of metformin; pregnancy with multiple fetuses.

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.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2006-06 with completion listed for 2011-01.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Birth Weight Per Arm (time frame: delivery).

It also tracked 12 secondary outcomes, for example Pregnancy Induced Hypertension Per Arm, Maternal Weight Gain Per Arm, Pre-eclampsia Per Arm, Mode of Delivery Per Arm, Gestational Weeks at Delivery Per Arm and Induction of Delivery Per Arm.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 221 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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