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Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
Plain-language guide to NCT02514954: phase 1 randomized trial of Insulin Lispro, 28 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02514954
- Phase
- phase 1
- Status
- completed
- Start
- 2015-07
- Completion (planned or actual)
- 2015-11
- Participants
- 28 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Type 1 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Lispro.
It had two arms (groups): BioChaperone® Combo (experimental) and Humalog® Mix25 (active comparator).
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 64 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes mellitus (as diagnosed clinically) \>= 12 months. Treated with multiple daily insulin injections or CSII \>= 12 months. BMI 18.5-28.0 kg/m\^2 (both inclusive).
The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; type 2 diabetes mellitus; previous participation in this trial. participation is defined as randomised.
How the Study Was Run
It was run as a randomized, crossover and triple-blind study.
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.
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, care provider and investigator.
It started in 2015-07 with completion listed for 2015-11.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Delta AUCBG,0-2h (time frame: 2 hours).
It also tracked 9 secondary outcomes, for example Delta AUCBG,0-6h, BGmax, tBGmax, AUCLisp,0-6h,, AUCGlarg,0-6h and Cmax,Lisp.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of 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; no results are posted to the registry yet, so nothing here describes outcomes.
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.