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A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1
Plain-language guide to NCT02221323: phase 2 randomized trial of Insulin Lispro, 18 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02221323
- Phase
- phase 2
- Status
- completed
- Start
- 2014-09
- Completion (planned or actual)
- 2014-11
- Participants
- 18 (actual)
- Design
- randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Insulin Lispro.
The results from this study may expand the knowledge on the severity of this issue and may provide evidence for future treatment recommendations regarding injection sites for insulin administration.
It had 1 arm (groups): Insulin lispro (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 18 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: AUCINS.0-4h and AUCGIR.0-4h during treatment period 1.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: AUCINS.0-4h and AUCBG.0-4h during treatment period 2, intra-subject variability of AUCINS.0-4h and AUCGIR.0-4h during treatment period 1.
How the Study Was Run
It was run as a randomized, single-group and open-label study.
Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2014-09 with completion listed for 2014-11.
It ran at 1 site in Germany.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: AUCINS.0-4h and AUCGIR.0-4h (time frame: up to 4 hours).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Insulin Lispro in 18 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.