Effect of Adding Metformin to Insulin in Uncontrolled Diabetic Patients During the 3rd Trimester of Pregnancy

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

There is now clear and unequivocal evidence that adverse pregnancy outcomes are strongly linked to maternal hyperglycemia, both in the peri-conception period and throughout gestation.

It had two arms (groups): Metformin Group (experimental) and Insulin alone group (experimental).

Will include 75 patients who will be treated with metformin ( 1gm with the 2 main meals ) combined with insulin therapy.

Will include 75 patients who will be treated with insulin alone.

The registry classes the interventions as drug.

Who Took Part

The registry lists 150 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: • Diabetic pregnant patients with single living fetus. Patients with gestational or type 2 diabetes. All patients require a dating ultrasound to confirm gestational age, viability and rule out multiple.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: patients with type 1 diabetes; patients with congestive heart failure or a history of congestive heart failure; patients with renal insufficiency.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Insulin (regular human) 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 Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2022-07-29 with completion listed for 2023-01-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Maternal glycemic control 3 months (time frame: 3 months). Maternal insulin requirements (time frame: 3 months). Maternal Blood glucose readings (time frame: 3 months).

It also tracked 5 secondary outcomes, for example Maternal weight gain, weekly fetal weight gain, fetal outcomes and Neonatal outcomes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 150 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.