Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Aspart and Insulin Detemir.

This trial is conducted in Africa, Europe, North and South America and Oceania.

The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).

It had two arms (groups): Insulin detemir (experimental) and Neutral Protamine Hagedorn (NPH) insulin (active comparator).

Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn.

Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn.

The registry classes the interventions as drug.

Who Took Part

470 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: Type 1 diabetes treated with insulin for at least 12 months.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: known or suspected hypersensitivity to the trial product(s) or related products; untreated hyperthyroidism or hypothyroidism; known or suspected abuse of alcohol or narcotics.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Aspart 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 Aspart study did not mask who received what.

It started in 2007-05 with completion listed for 2010-08.

It ran at 98 sites in United Kingdom (14), Canada (10), France (10), Australia (9), Poland (9) and Argentina (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36 (time frame: At gestational week (GW) 36). Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36 (time frame: At gestational week (GW) 36).

It also tracked 45 secondary outcomes, for example Glycosylated Haemoglobin (HbA1c) During Pregnancy, Fasting Plasma Glucose (FPG), 8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24, 8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36, Maternal Safety - Number of Subjects With Adverse Events (AEs) and Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 470 people.

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

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