Study of LY2409021 in Participants With Type 1 Diabetes

What Was Tested

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

This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m\^2).

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening; are pregnant or intend to become pregnant during the course of the study; women who are breastfeeding.

How the Study Was Run

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

Because people in this Glucagon 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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2012-07 with completion listed for 2012-09.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glucagon compound page, all human trials.