A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

This trial is conducted in Europe.

The aim of this clinical trial is to investigate the blood glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type 1 diabetes.

It had two arms (groups): IDeg (experimental) and IGlar (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 27 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: Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group). Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index 18.0-28.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 3 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.

How the Study Was Run

Design: randomized, crossover and double-blind.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2009-08 with completion listed for 2009-11.

It ran at 1 site in Austria.

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 27 people.

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

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.