A Study of a New Type of Insulin in Participants With Type 2 Diabetes on Insulin Injection Therapy

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

The study will be conducted in participants with type 2 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 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Are male or female participants with Type 2 Diabetes Mellitus (T2DM). Have a body mass index (BMI) no greater than 35.0 kilogram per square meter (kg/m²). 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.

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

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

Neither the participants nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

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 Glucose Following a Mixed Meal.

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It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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