A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Lispro.

The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.

It had two arms (groups): LY900014 (experimental) and Insulin Lispro (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 49 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months. Using an insulin pump with 'rapid-acting insulin' for at least 6 months and using the same rapid-acting insulin for at least the past 30 days. Have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring (FGM) for at least 60 days during the past 12 months. Have a body mass index (BMI) of ≤35 kilograms per meter squared at screening.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: have had more than 1 emergency treatment for very low blood glucose in the last 6 months; have had more than 1 emergency treatment for poor glucose control (hyperglycemia or diabetic ketoacidosis) in the last 6 months; taking certain diabetes medications that are not allowed for study participation.

How the Study Was Run

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

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.

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 2018-02-21 with completion listed for 2018-09-04.

It ran at 5 sites in United States (3) and Spain (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Rate of Infusion Set Failures (time frame: 6 Weeks).

It also tracked 6 secondary outcomes, for example Percentage of Participants With at Least 1 Event of Infusion Set Failure, Rate of Premature Infusion Set Changes, Time Interval Until Infusion Set Change and Number of Participants With Severe Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in 49 people.

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.