A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

What Was Tested

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

The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).

It had four arms (groups): LY900014 (experimental), Insulin Lispro (Humalog) (active comparator), LY900014 Maximum Extended Enrollment (MEE) (experimental) and Insulin Lispro (Humalog) MEE (active comparator).

The registry classes the interventions as drug.

Who Took Part

933 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 (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening. Have been treated for at least 90 days prior to screening with:. Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily. Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:. Dipeptidyl peptidase-4 (DPP-4) inhibitor.

The full record lists 13 inclusion and 5 exclusion criteria; among the exclusions: have been diagnosed, at any time, with type 1 diabetes (t1d) or latent autoimmune diabetes in adults; have hypoglycemia unawareness as judged by the investigator; have had any episode of severe hypoglycemia within the 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 Glargine 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.

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 2017-07-14 with completion listed for 2018-08-14.

It ran at 141 sites in United States (32), Japan (22), South Korea (14), India (12), Germany (9) and Argentina (7).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 10 secondary outcomes, for example Rate of Severe Hypoglycemia, Rate of Documented Symptomatic Hypoglycemia, 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 and Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 933 people.

With 933 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.