A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating.

For each participant, the study will last about two to nine weeks.

The registry classes the interventions as drug.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female participants with type 1 diabetes. Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive. Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%). Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: known or suspected hypersensitivity to investigational medical product(s) or related products; known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption; proliferative retinopathy or maculopathy as judged by the investigator based on a recent (less than 1.5 years) ophthalmologic examination.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

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 2020-02-25 with completion listed for 2020-08-10.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus (time frame: Day 1: Baseline up to 5 hours after missed meal bolus). Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension (time frame: Day 2: Baseline up to 5 hours after pump suspension).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 32 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 Lispro compound page, all human trials.