Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

What Was Tested

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

This trial is conducted in Europe.

The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.

It had two arms (groups): Glycerol (experimental) and Mannitol (active comparator).

The registry classes the interventions as drug.

Who Took Part

34 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 and 27 kg/m\^2, inclusive.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: known or suspected allergy to trial products or related products; previous participation in this trial; the receipt of any investigational drug within the last 3 months prior to this trial.

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.

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 2005-11 with completion listed for 2006-02.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum insulin detemir concentration curve. Maximum serum insulin concentration.

It also tracked 7 secondary outcomes, for example Area under the glucose infusion rate curve, Time to maximum serum insulin concentration, Terminal serum insulin half life, Area under the serum insulin detemir concentration curve, Maximum glucose infusion rate and Time to maximum glucose infusion rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Detemir in 34 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.