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A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements
Plain-language guide to NCT02152384: phase 1 randomized trial of Insulin Glargine and Insulin Lispro, 28 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02152384
- Phase
- phase 1
- Status
- completed
- Start
- 2014-06
- Completion (planned or actual)
- 2014-12
- Participants
- 28 (actual)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Insulin Glargine and Insulin Lispro.
It had two arms (groups): Insulin peglispro (LY2605541, with Insulin Lispro) (experimental) and Insulin Glargine (with Insulin Lispro) (active comparator).
Insulin peglispro (LY2605541) once daily subcutaneous (SC) injection at bedtime. Insulin lispro given SC prandially or as bolus as required.
Insulin glargine once daily SC injection at bedtime. Insulin lispro given SC prandially or as a bolus as required.
The registry classes the interventions as drug.
Who Took Part
28 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have C-peptide \<0.3 nanomoles per liter (nmol/L). Are able and willing to eat the protocol specified standard breakfast and other meals as required.
How the Study Was Run
Design: randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2014-06 with completion listed for 2014-12.
It ran at 1 site in Germany.
Its stated primary purpose is basic science.
What Was Measured
It also tracked 6 secondary outcomes, for example Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Glargine and Insulin Lispro in 28 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 Glargine compound page and the Insulin Lispro compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.