A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes

What Was Tested

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

This trial is conducted in Japan.

The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.

It had two arms (groups): A (experimental) and B (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 20 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. Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months.

The full record lists 4 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 (only clamp period).

How the Study Was Run

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

Because people in this Insulin Detemir 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 Detemir and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Detemir.

Those kept unaware of assignments: participant and investigator.

It started in 2010-06 with completion listed for 2010-10.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the NN1250 GIR (glucose infusion rate) curve.

It also tracked 1 secondary outcome, for example Area under the serum insulin detemir concentration-time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Detemir in 22 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 Detemir compound page, all human trials.