A Trial Investigating the Relationship Between Pharmacodynamic and Interstitial Concentration for Insulin Detemir and Human Insulin

What Was Tested

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

This study is conducted in Europe.

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

Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order).

Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order).

Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order).

The registry classes the interventions as drug.

Who Took Part

The registry lists 13 actual participants took part.

It was open to men only aged from 19 years up to 50 years.

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

Examples of who could join: Healthy males between 19 and 50 years inclusive. Body Mass Index (BMI) below 27 kg/m\^2.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: participation in any other clinical trial involving other investigational products within the last 3 months.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 1999-10 with completion listed for 1999-12.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Steady state glucose infusion rate (GIR) / interstitial insulin steady state concentration (time frame: 8 hours).

It also tracked 4 secondary outcomes, for example Steady state glucose infusion rate (GIR), Steady state insulin interstitial concentration, Ratio of steady state serum insulin concentration to interstitial insulin concentration and Insulin concentration profiles.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Insulin Detemir in 13 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 (regular human) compound page and the Insulin Detemir compound page, all human trials.