Comparison of Insulin Alone to Insulin With Metformin to Treat Gestational Diabetes Mellitus

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

In pregnancy, insulin alone has traditionally been used, though some advocate the use of metformin alone as primary therapy.

There have been no trials published to date specifically comparing combination therapy to insulin alone.

Control of blood glucose will be determined by hemoglobin A1c at the time of delivery.

Who Took Part

The registry lists 1 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Able to read and write English and/or Spanish and give written consent. Diagnosis of GDM, defined as an abnormal glucose tolerance test performed after 12 weeks gestation using 1 of the 2 criteria below:.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: pre-existing dm either by diagnosis preceding pregnancy or hemoglobin a1c \>6.5 collected during the current pregnancy; uncontrolled chronic hypertension, as this may alter maternal and perinatal outcomes measured; multiple gestations.

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.

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

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2018-01-03 with completion listed for 2019-07-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hgb A1c (time frame: collected at the time of delivery).

It also tracked 15 secondary outcomes, for example Glucose control, Incidence of maternal hypoglycemia, Change in hemoglobin A1c over the course of the pregnancy, Incidence of maternal side effects, Treatment acceptability and Maternal weight gain.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 1 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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