DETERMINE: Detemir vs NPH

What Was Tested

This registered phase 2 trial tested Insulin Detemir and NPH Insulin (isophane).

The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

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

Patients are to receive insulin detemir as long acting insulin to control blood sugars.

Patients are to receive insulin NPH as long acting insulin to control blood sugars.

The registry classes the interventions as drug.

More on the Plan

Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established.

At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH.

The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy.

Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy.

Who Took Part

The registry lists 336 planned participants were the target.

It was open to people of any sex 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: Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.

The full record lists 1 inclusion and 9 exclusion criteria; among the exclusions: multiple gestation; type 1 diabetes mellatus; age \< 18.

How the Study Was Run

Design: 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.

Everyone knew when Insulin Detemir was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-02-01 with completion listed for 2025-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Neonatal Hypoglycemia (time frame: Within the first 24 hours of life). Prolonged neonatal hypoglycemia (time frame: Neonatal hypoglycemia after the 1st 24 hours of life but before discharge).

It also tracked 17 secondary outcomes, for example Neonatal Gastrin Level, Neonatal C-Peptide Level, Neonatal insulin level, Neonatal leptin level, Rates of pregnancy induced hypertension and Mode of delivery.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 336 people.

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

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