A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy

What Was Tested

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

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).

It had two arms (groups): Insulin Lispro (Humalog) (active comparator) and Ultra-Rapid Lispro (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 471 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: Have been diagnosed with T1D and continuously using insulin for at least 1 year. Have been using CSII therapy for a minimum of 6 months.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: have hypoglycemia unawareness; have had more than 1 episode of severe hypoglycemia within 6 months prior to screening; have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2019-02-14 with completion listed for 2020-01-06.

It ran at 83 sites in United States (32), Germany (8), Canada (6), France (6), Spain (6) and Australia (5).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 12 secondary outcomes, for example Rate of Severe Hypoglycemia at Week 16, Rate of Documented Symptomatic Hypoglycemia at Week 16, Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16 and Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Lispro in 471 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.