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

What Was Tested

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

This study has 2 parts.

Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period.

Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.

It had two arms (groups): LY2605541 (experimental) and Insulin Glargine (active comparator).

The registry classes the interventions as biological.

Who Took Part

25 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: Otherwise fit and healthy.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: taking medication or supplements other than insulin to control diabetes; suffered a hypoglycemic event in the last 12 months that required hospitalization or has poor awareness of hypoglycemia.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2013-02 with completion listed for 2013-12.

It ran at 1 site in Germany.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Concentration of Epinephrine (time frame: 30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp).

It also tracked 6 secondary outcomes, for example Concentration of Cortisol, Concentration of Glucagon, Concentration of Growth Hormone and Concentration of Norepinephrine.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 25 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 Insulin Glargine compound page, all human trials.