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A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants

Plain-language guide to NCT03286751: phase 1 randomized trial of Insulin Lispro, 42 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03286751
Phase
phase 1
Status
completed
Start
2017-10-13
Completion (planned or actual)
2018-02-06
Participants
42 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Diabetes Mellitus, Type 2
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 1 trial tested Insulin Lispro.

This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog).

Both drugs are given by injection under the skin of the abdomen.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 42 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion). Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²). Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results. Are nonsmokers, have not smoked for at least 6 months prior to entering the study.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: are currently participating in or completed a clinical trial within the last 30 days; have previously participated or withdrawn from this study.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant and investigator.

It started in 2017-10-13 with completion listed for 2018-02-06.

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 Glucodynamics: Total Amount of Glucose Infused (Gtot).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 42 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.

Our Notes on the Compound

Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.