A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

This trial was conducted in Europe.

The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.

It had four arms (groups): A1, first period (experimental), A2, second period (active comparator), B1, first period (active comparator) and B2, second period (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 39 actual participants took part.

It was open to people of any sex aged from 6 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 6-65 years (both inclusive). Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index for children: 15.0-20.0 kg/m\^2 (both inclusive), for adolescents: 18.0-28.0 kg/m\^2 (both inclusive) and for adults maximum 30.0 kg/m\^2.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: not able or willing to refrain from smoking during the inpatient period; female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods.

How the Study Was Run

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

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.

Each person switched between Insulin Glargine 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 Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2009-12 with completion listed for 2010-05.

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 39 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.