Within-subject Variability of Insulin Detemir in Healthy Volunteers

What Was Tested

This registered phase 1 trial tested Insulin Glargine and Insulin Detemir.

This trial is conducted in Europe.

The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

It had two arms (groups): Insulin detemir (experimental) and Insulin glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Healthy Japanese men or women. Holding a Japanese pass-port and Japanese-born parents. Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator. Body Mass Index (BMI) between 18 and 30 kg/m\^2, incl.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: subject with history of alcohol or drug dependence.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2004-05-27 with completion listed for 2004-10-31.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Maximum glucose infusion rate (GIRmax).

It also tracked 5 secondary outcomes, for example Area under the glucose infusion rate curve (AUCGIR), Time to maximum glucose infusion rate (tGIRmax), Area under the insulin concentration curve (AUC), Maximum insulin concentration (Cmax) and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Detemir in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Insulin Detemir compound page, all human trials.