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Bioequivalence of Two Lispro Formulations
Plain-language guide to NCT01133392: phase 1 randomized trial of Insulin Lispro, 41 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01133392
- Phase
- phase 1
- Status
- completed
- Start
- 2010-05
- Completion (planned or actual)
- 2010-08
- Participants
- 41 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy Volunteers
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Lispro.
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
It had two arms (groups): Insulin Lispro A (experimental) and Insulin lispro B (active comparator).
The registry classes the interventions as drug.
More on the Plan
The 2 formulations of insulin lispro will be referred to here as: Lispro A Lispro B.
Who Took Part
The registry lists 41 actual participants took part.
It was open to people of any sex aged from 21 years up to 50 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Are healthy males or females. Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m\^2). Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.
The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: history of first-degree relatives known to have diabetes mellitus; evidence of an acute infection with fever or infectious disease; intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
How the Study Was Run
The set-up was randomized, crossover and open-label.
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.
Everyone knew when Insulin Lispro was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2010-05 with completion listed for 2010-08.
It ran at 1 site in Singapore.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Lispro in 41 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.