A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 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 (active comparator).

The registry classes the interventions as drug.

Who Took Part

628 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 T2D based on the disease diagnostic criteria World Health Organization (WHO) classification. Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs). Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: participants must not have been diagnosed, at any time, with type 1 diabetes (t1d) or latent autoimmune diabetes in adults; participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening; participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.

How the Study Was Run

Design: 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.

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 2019-05-27 with completion listed for 2021-01-20.

It ran at 41 sites in China (34), Mexico (4) and Argentina (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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 Postmeal 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 628 people.

With 628 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.