A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

What Was Tested

The trial (phase 1) is built around Insulin Glargine.

This trial was conducted in Europe.

The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

66 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index 18.0-28.0 kg/m\^2.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period; supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmhg for systolic or 50-90 mmhg for diastolic.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2010-05-03 with completion listed for 2010-08-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 66 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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