RCT Glargine vs NPH for Treatment of DM in Pregnancy

What Was Tested

This registered phase 3 trial tested Insulin Glargine and NPH Insulin (isophane).

The researchers are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy.

Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin.

Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients.

It had two arms (groups): Insulin Glargine (active comparator) and Insulin NPH (active comparator).

Insulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.

Insulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.

The registry classes the interventions as drug.

More on the Plan

Patients will be randomized to either be treated with NPH insulin for management of diabetes mellitus in pregnancy, or with Glargine insulin.

Their primary outcome is hypoglycemia.

The researchers provide patients with insulin teaching, a referral to diabetic nutrition education, and instructions for hypoglycemic events.

The study is voluntary, and the patients will receive the same care and number of visits regardless of whether they choose to participate in the study or not, regardless of which arm they are in within the RCT.

Who Took Part

The registry lists 160 planned participants were the target.

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: Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy. At least 18 years old. Insulin started prior to 34 weeks gestation. Established prenatal care by 14 weeks gestation.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: those under the age of 18 years old; those unable to consent in english; allergy to insulin.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2024-04-01 with completion listed for 2026-04-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Hypoglycemia (time frame: From initiation of insulin therapy to delivery).

It also tracked 2 secondary outcomes, for example Large for Gestational Age and Shoulder dystocia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and NPH Insulin (isophane) in 160 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the NPH Insulin (isophane) compound page, all human trials.