Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human) and Insulin Aspart.

The registry classes the interventions as drug.

Who Took Part

The registry lists 16 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening. AGe: 18-60 years. No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination. Written informed consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: pregnant women or patients planning to become pregnant during the investigation period; patient lacking the ability to sens insulin sensitivity; serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

It started in 2004-11 with completion listed for 2006-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Meal-regulated insulin time two peaks after the two intervention periods.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 16 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Insulin Aspart compound page, all human trials.