A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

The aim of this open label feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM).

It had two arms (groups): Current Standard Care (active comparator) and Treatment (active comparator).

Insulin + Metformin.

Glibenclamide + Metformin.

The registry classes the interventions as drug.

Who Took Part

23 actual participants took part.

It was open to women only aged from 16 years up to 50 years.

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

Examples of who could join: Inadequate glycaemic control is defined according to the SIGN 116 guidelines.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: pregnant women requiring insulin prior to 20 weeks gestation or after 36 weeks gestation; patients with suspected type 1 diabetes mellitus presenting in pregnancy; women with allergies to either glibenclamide or insulin or any of their excipients.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Being open-label, the Insulin (regular human) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-07 with completion listed for 2015-10.

It ran at 5 sites in United Kingdom (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of women willing to be randomised (time frame: 2 years).

It also tracked 6 secondary outcomes, for example Glycaemic control, Patient satisfaction, Clinical outcomes, Clinical outcome, Clinical Outcome and Clinical Outcome.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 23 people.

Its size is small, so on its own it can only give an early look.

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.