A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects

What Was Tested

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

This trial is conducted in Europe.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 84 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male, aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index 18.5-28.0 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; previous participation in this trial. participation is defined as signed informed consent; any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol.

How the Study Was Run

Design: randomized, single-group and double-blind.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

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

Those kept unaware of assignments: participant and investigator.

It started in 2015-06 with completion listed for 2015-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of treatment-emergent adverse events (time frame: From the time of trial product administration and until 12 days after trial product administration).

It also tracked 2 secondary outcomes, for example Area under the serum insulin concentration-time curve and Area under the glucose infusion rate-time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 84 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.