The Impact of Liraglutide on Glucose Tolerance and the Risk of Type 2 Diabetes in Women With Previous Pregnancy-induced Diabetes

What Was Tested

This registered phase 4 trial tested Liraglutide.

It is well-known that women with previous gestational diabetes mellitus are in risk of developing type 2 diabetes later in life; approximately half of the women develop overt type 2 diabetes within the first 10 years after pregnancy.

It had three arms (groups): Liraglutide (experimental), Placebo (placebo comparator) and Control (no intervention).

Placebo, subcutaneous, once-daily for one year.

Control without previous GDM.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 105 actual participants took part.

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

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

Examples of who could join: Informed oral and written consent. Age \>18 years. 25 kg/m2 \< BMI \< 45 kg/m2. NGT, IFG and or IGT.

The full record lists 6 inclusion and 46 exclusion criteria; among the exclusions: patients with diabetes; patients with previous pancreatitis or previous neoplasia; pregnant or breast feeding women.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Liraglutide 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.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-07 with completion listed for 2019-09.

It ran at 1 site in Denmark.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Change in glucose tolerance (time frame: from baseline to 52 wks, 53 wks, 260 wks, and 261 wks).

It also tracked 1 secondary outcome, for example Deterioration in glycaemic status.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 105 people.

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

More context: the Liraglutide compound page, all human trials.