Pharmacokinetics of Insulin Detemir in Healthy Volunteers From Taiwan

What Was Tested

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

This trial is conducted in Asia.

It had 1 arm (groups): Insulin detemir (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to men only 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 and 27 kg/m\^2, inclusive. Non-smoker or smoking maximum 5 cigarettes per day or the equivalent.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: participation in any other clinical trial involving other investigational products within the last 3 months; subject with a history of alcohol or drug dependence; subject with a first-degree relative with diabetes mellitus.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Being open-label, the Insulin Detemir study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-08 with completion listed for 2005-12.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the insulin detemir concentration curve.

It also tracked 4 secondary outcomes, for example Maximum insulin detemir concentration, Time to maximum insulin detemir concentration, The mean residence time of insulin detemir and Insulin detemir half-life.

What This Means in Plain Language

Put simply, this is a phase 1, non-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.