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A Study of LY900014 Formulation in Healthy Participants
Plain-language guide to NCT02942654: phase 1 randomized trial of Insulin Lispro, 32 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02942654
- Phase
- phase 1
- Status
- completed
- Start
- 2016-11
- Completion (planned or actual)
- 2016-12
- Participants
- 32 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Healthy
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Lispro.
This study evaluates a new formulation of LY900014, a drug that lowers blood sugar.
It is administered by injection under the skin of the abdomen.
It had two arms (groups): LY900014 (experimental) and Insulin Lispro (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 32 actual participants took part.
It was open to people of any sex aged from 21 years up to 70 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion). Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²), inclusive, at screening. Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the 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.
In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.
Blinding on both sides kept the participants and researchers unaware of who received Insulin Lispro.
Those kept unaware of assignments: participant and investigator.
It started in 2016-11 with completion listed for 2016-12.
It ran at 1 site in Singapore.
Its stated primary purpose is basic science.
What Was Measured
It also tracked 1 secondary outcome, for example Glucodynamics (GD): 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 32 people.
Its size is small, so on its own it can only give an early look.
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.