Gestational Diabetes: Insulin or Oral Hypoglycemic Agents?

What Was Tested

The trial (phase 3) is built around Insulin (regular human).

Gestational diabetes mellitus takes place in 2 steps.

First, it is the consequence of insulin resistance due to the modifications of the pregnancy hormonal environment, and second, of the deficiency of the beta cells of the pancreas to respond by a sufficient insulin secretion.

This physiopathology is closely connected to the one of type 2 diabetes.

It had two arms (groups): Insulin (active comparator) and Oral Hypoglycemic Agents (experimental).

Rapid acting insulin and long acting insulin.

Metformin + glyburide + insulin if needed.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 73 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: Age ≥ 18 yrs,. With gestational diabetes at 24-28 weeks (Canadian Diabetes Association (CDA) criteria),. To understand and read French or English.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: known type 1 or type 2 diabetes,; treatment interfering with glucose metabolism,; allergies to one of the components of the treatment,.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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 2010-08 with completion listed for 2014-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glycemic control (time frame: 36 and 37th week of gestation).

It also tracked 1 secondary outcome, for example Acceptability of the treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 73 people.

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.