Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes

What Was Tested

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

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

Standard protocol of insulin treatment for gestational diabetes.

The registry classes the interventions as drug and other.

More on the Plan

An alternative is the use of oral antidiabetic agents like glibenclamide.

Progress of the study: Inclusion of women between 24 and 34 weeks.

Randomization between Insulin and Glibenclamide after failure of 10 days of dietary treatment well done.

Routine monitoring of pregnant women with gestational diabetes, up to a week after delivery Number of clinical sites: 15 Perspective: Use of Glibenclamide as a first line treatment of gestational diabetes requiring drug treatment.

Who Took Part

Enrollment: 914 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: Gestational diabetes diagnosed between 24 and 34 weeks according to international criteria.

The full record lists 1 inclusion and 13 exclusion criteria; among the exclusions: multiple pregnancy; chronic hypertension; renal impairment.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-05-18 with completion listed for 2017-03-15.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 914 people.

With 914 participants it is a large trial for this field.

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

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