A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

This is a two-period study of participants with type 1 diabetes mellitus (T1DM).

Participants will continue to use meal time insulin throughout the study.

It had three arms (groups): Insulin Peglispro/Insulin Glargine (experimental), Insulin Glargine/Insulin Peglispro (active comparator) and Control (no intervention).

Control Arm. Untreated healthy participants.

The registry classes the interventions as biological.

Who Took Part

Enrollment: 27 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Otherwise fit and healthy.

The full record lists 2 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 have poor awareness of hypoglycemia.

How the Study Was Run

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

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

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-11 with completion listed for 2015-10.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM).

It also tracked 5 secondary outcomes, for example Lipid Oxidation in T1DM and Healthy Participants, Basal Metabolic Rate (BMR) for T1DM, Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants, Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants and Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 27 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.