Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus

What Was Tested

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

This trial is conducted in Europe.

It had two arms (groups): IDeg (experimental) and IGlar U300 (active comparator).

The registry classes the interventions as drug.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female aged 18-64 years (both inclusive) at the time of signing informed consent. Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening. Body mass index 18.5-29.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 2 exclusion criteria.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2015-08-31 with completion listed for 2016-04-14.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the glucose infusion rate curve.

It also tracked 1 secondary outcome, for example Area under the glucose infusion rate curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 60 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, all human trials.