Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)

What Was Tested

The trial (phase 3) is built around Liraglutide.

GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy.

It had two arms (groups): Metformin XR plus liraglutide (experimental) and Metformin XR plus placebo (active comparator).

The registry classes the interventions as drug.

More on the Plan

Gestational diabetes is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. .

The higher rates were in studies of particular ethnic groups in the U.S.

However, the risk factors are unable to predict all cases of subsequent type 2 diabetes: the biggest risk factor is a GDM pregnancy.

Studies are needed for optimal postpartum and long-term health of women who have had GDM.

Who Took Part

Enrollment: 153 actual participants took part.

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

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

Examples of who could join: Adult female 18 years to 45 years of age who experienced GDM within 52 weeks of index pregnancy. Actual BMI \>25 kg/ m2. Written consent for participation in the study. Patient completed lactation.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: history of pancreatitis; serum liver enzymes (ast and/or alt levels) exceeding more than twice normal laboratory values; uncontrolled hypertension (systolic blood pressure\>150 mm hg and/or diastolic blood pressure \>90 mm hg).

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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 2011-08-11 with completion listed for 2019-04-24.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Insulin Secretion-Sensitivity Index (IS-SI) (time frame: 84 weeks of treatment).

It also tracked 21 secondary outcomes, for example Fasting Blood Glucose (FBG), Mean Glucose During OGTT (MBG), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), Matsuda Insulin Sensitivity Index Derived From OGTT, Insulinogenic Index (IGI) /HOMA-IR and Absolute Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 153 people.

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

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