A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.

Screening is required within 28 days prior to the start of the study.

For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.

It had four arms (groups): Elderly Adults LY900014 (experimental), Elderly Adults Insulin Lispro (active comparator), Younger Adults LY900014 (experimental) and Younger Adults Insulin Lispro (active comparator).

The registry classes the interventions as drug.

Who Took Part

80 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: Are male or female participants with Type 1 Diabetes Mellitus (T1DM). Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²). Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%). Have had no episodes of severe hypoglycaemia in the last 6 months.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: have a history of renal impairment; have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives; have proliferative retinopathy or maculopathy and/or severe neuropathy.

How the Study Was Run

Design: randomized, crossover 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.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2017-05-24 with completion listed for 2017-11-18.

It ran at 2 sites in Germany (2).

Its stated primary purpose is basic science.

What Was Measured

It also tracked 1 secondary outcome, for example Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 80 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.