A Study of LY900014 in Participants With Type 1 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Lispro.

It had six arms (groups): LY900014 (experimental), Insulin Lispro (Humalog) (active comparator), LY900014 Postmeal (Open Label) (experimental), LY900014 - Maximum Extended Enrollment (MEE) (experimental) and Insulin Lispro (Humalog)-MEE (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1392 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 T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year. Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin. Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening; have had more than 1 severe hypoglycemic episode within 6 months of screening; have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of 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.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2017-07-17 with completion listed for 2018-09-06.

It ran at 172 sites in United States (44), Japan (19), Poland (11), Germany (10), Romania (10) and Argentina (9).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Rate of Severe Hypoglycemia at Week 26, Rate of Documented Symptomatic Hypoglycemia at Week 26, Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26, Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26, Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26 and Change From Baseline in HbA1c at Week 52.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 1392 people.

With 1392 participants it is a large trial for this field.

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.