A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Insulin Lispro.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 354 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: Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year. Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily. Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days prior to screening; participants must not have had more than 1 severe hypoglycemic episode within 6 months prior to screening; participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months prior to screening.

How the Study Was Run

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

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2019-05-29 with completion listed for 2022-01-10.

It ran at 30 sites in China (24), Argentina (3) and Mexico (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 26).

It also tracked 8 secondary outcomes, for example 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT), 2-hour PPG Excursion During MMTT, Rate of Severe Hypoglycemia, Rate of Documented Symptomatic Post Meal Hypoglycemia and Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 354 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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