A Study of LY2605541 and Glargine and Exercise in Participants With Type 1 Diabetes

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

The purpose of this study is to measure how much of the study drug or insulin glargine gets into the blood stream and how long it takes the body to get rid of it.

The effect of exercise will also be evaluated.

This study has two parts.

It had six arms (groups): LY2605541 (Part A) (experimental), Glargine (Part A) (active comparator), First LY2605541 + Exercise,Then LY2605541 Alone (Part B) (experimental), First LY2605541 Alone, Then LY2605541 + Exercise (Part B) (experimental) and First Glargine + Exercise, Then Glargine Alone (Part B) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 76 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) of 18 to 30 kilograms per meter squared (kg/m\^2), inclusive. Have a fasting c-peptide \<0.3 nanomoles per liter (nmol/L). Perform regular physical cardiorespiratory activity to achieve an average total energy expenditure of ≥500 metabolic equivalent of task (MET)-minutes per week during the last 3 months prior to screening.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: have known allergies to ly2605541, insulin glargine, related compounds or any components of the formulation; have a history of hypoglycemia unawareness; currently smokes \>5 cigarettes per day, or are unwilling to comply with study requirements regarding smoking or use of tobacco products.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2013-02 with completion listed for 2013-11.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 76 people.

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

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