MeDiGes Study: Metformine Use in Gestational Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Detemir.

Women with gestational diabete (GD) who do not meet glycemic control objectives with diet will be assigned to two treatment groups randomly.

The Metformin group may additionally receive insulin in a second time in case the glycemic control is not appropriate with monotherapy.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 200 actual participants took part.

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

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

Examples of who could join: 18-45 years old. 2nd or 3rd trimesters of pregnancy. Able to give informed consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: psychopathological situations that do not guarantee proper adhesion to follow up; 1st trimester of pregnancy; patients who can not attend the scheduled consultation.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Detemir 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 Detemir was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-10-26 with completion listed for 2020-05-28.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Good glycemic control (time frame: 50 weeks). Baby wellness (time frame: Delivery).

It also tracked 9 secondary outcomes, for example Adverse event profile, Fructosamine as a marker of insulinization, Satisfaction with the treatment, IL-6 profile, IL-10 profile and oxidativge stress as well as in lipid profile and Leptin profile.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Detemir in 200 people.

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

More context: the Insulin Detemir compound page, all human trials.