A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

What Was Tested

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

This study has two parts.

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

Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.

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

The registry classes the interventions as biological.

Who Took Part

The registry lists 15 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 3 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; taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

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

It started in 2013-10 with completion listed for 2014-12.

It ran at 1 site in Denmark.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations (time frame: Day 22: 240 minutes (min) to 420 min). VLDL-TG Secretion Rate (time frame: Day 22: 240 min to 420 min). VLDL-TG Oxidation Rate (time frame: Day 22: 240 min to 420 min).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 15 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.