Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Detemir.

It had two arms (groups): Neutral Protamine Hagedorn (NPH) (active comparator) and Detemir (active comparator).

NPH will peak between 4-12 hours after injection with a duration of action around 14 hours.

Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours).

The registry classes the interventions as drug.

Who Took Part

The registry lists 108 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: Preexisting type 2 diabetes mellitus requiring medical treatment or. Gestational age ≤20 weeks. Willing to start insulin therapy or to continue insulin treatment during pregnancy. Singleton or twin pregnancy.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: known allergy/prior adverse reaction to nph/detemir; patients \<18y; known major fetal anomalies.

How the Study Was Run

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

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

The Insulin Detemir group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Detemir study: the participants and staff both knew the treatment.

It started in 2018-09-04 with completion listed for 2020-07-29.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Neonates With Composite Adverse Neonatal Outcome (time frame: From the time of delivery to the time of discharge (about 2-14 days)).

It also tracked 13 secondary outcomes, for example Maternal Mean Fasting Glucose, Maternal Mean Post Prandial Glucose, Change in Maternal Weight During Pregnancy, Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy, Number of Maternal Subjects Who Had Preeclampsia With Severe Features and Number of Subjects Who Had Cesarean Delivery.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 108 people.

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

More context: the Insulin Detemir compound page, all human trials.