Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy

What Was Tested

The trial (not phased) is built around Insulin (regular human) and Insulin Detemir.

The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin.

These women are diagnosed with gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2 diabetes (T2DM) at the onset of pregnancy.

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

The registry classes the interventions as drug.

More on the Plan

Perinatologists managing the patient in DIPP determine when patients need further treatment with medical therapy.

After verbally counseling the patient, she will be recruited for the study by the investigators.

An extensive explanation of the objectives of the study will be presented to the patient, as well as written copies of the protocol and consent.

After informed consent is given, patients will be randomized to management with either insulin NPH or detemir together with rapid acting insulin aspart (Novolog) with meals, as necessary.

Who Took Part

Enrollment: 105 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women with known preexisting type 2 diabetes that are in need of medical therapy.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: patients \<18 years of age; a diagnosis of gdm outside of the gestational age stated above; known allergy/prior adverse reaction to insulin nph or insulin detemir.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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 2013-03 with completion listed for 2015-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycemic Control (time frame: up to 41 weeks).

It also tracked 15 secondary outcomes, for example Number of Patients Obtaining Glycemic Control, Time to Achieve Glycemic Control, Average Fasting Glucose, Post-prandial Blood Glucose, Weight Gain and Neonatal Weight.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Insulin Detemir in 105 people.

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 and the Insulin Detemir compound page, all human trials.