A Study of a New Type of Insulin in Participants With Type 1 Diabetes on Insulin Injection Therapy

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels.

Side effects and tolerability will be documented.

The study will be conducted in two parts (Part A and Part B) to achieve its objectives.

It had four arms (groups): Part A:Insulin Lispro Test (experimental), Part A:Insulin Lispro Reference (active comparator), Part B:Insulin Lispro Test (experimental) and Part B:Insulin Lispro Reference (active comparator).

The registry classes the interventions as drug.

Who 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: Are male or female participants with type 1 diabetes mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin. Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening. Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study. Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party). Have venous access sufficient to allow for blood sampling.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2018-01 with completion listed for 2018-04.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: (Part B) PK: AUC of Insulin Lispro.

It also tracked 2 secondary outcomes, for example (Part B) PD: AUC of Glucose Following a Meal.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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