Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin.

Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes.

What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 31 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: Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control. Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria. Less than 24 weeks at study enrollment. Singleton or twin pregnancy. English or Spanish speaking.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: end organ complications of diabetes (retinopathy, renal insufficiency, etc.); prior need for insulin for glycemic control; history of diabetic ketoacidosis (dka) or hyperosmolar state.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2008-08 with completion listed for 2010-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Blood Glucose Measurements (time frame: Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery).

It also tracked 8 secondary outcomes, for example Number of Patients With Obstetric Complications, Maternal Weight Gain, Number of Babies With Neonatal Hypoglycemia, Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester, Number of Episodes Maternal Hypoglycemia and Number of Babies With Adverse Neonatal Outcomes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 31 people.

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

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

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