Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Detemir.

This trial is conducted in Asia.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Body mass index (BMI) between 18 and 25 kg/m\^2 (both inclusive). Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; previous participation in this trial. participation is defined as randomisation; receipt of any investigational drug within the last three months prior to this trial.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2007-08 with completion listed for 2007-09.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the insulin detemir concentration curve (time frame: from time zero to 24 hour).

It also tracked 7 secondary outcomes, for example Area under the insulin detemir concentration curve, Maximum serum insulin detemir concentration, Time to maximum serum insulin detemir concentration, Mean residence time (MRT), Terminal half-life and Insulin detemir clearance.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Detemir in 20 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.