Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects

What Was Tested

This registered phase 1 trial tested Insulin Detemir.

This trial is conducted in Europe.

It had two arms (groups): Treatment period 1 (experimental) and Treatment period 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

37 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator. Body mass index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: known or suspected allergy to trial products or related products; A history of alcohol or drug abuse.

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 Detemir group and the comparison group should start out alike.

Each person switched between Insulin Detemir and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant and investigator.

It started in 2006-08 with completion listed for 2006-11.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUC0-36h, area under the serum insulin detemir concentration curve (time frame: From 0 to 36 hours). Cmax, maximum serum insulin detemir concentration.

It also tracked 5 secondary outcomes, for example AUC, area under the serum insulin detemir concentration curve, Time to maximum concentration (tmax), Terminal half life (t½), Area under the Curve Glucose Infusion Rate (AUCGIR) and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Detemir in 37 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.