Safety of NNC 0123-0000-0338 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

The registry lists 70 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: Body mass index (BMI) between 18 and 28 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2011-04-11 with completion listed for 2011-09-16.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of adverse events.

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 70 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.