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A Study on the Effect of 2 Pen Devices on HbA1c
Plain-language guide to NCT00985712: phase 4 randomized trial of Insulin Lispro, 263 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00985712
- Phase
- phase 4
- Status
- completed
- Start
- 2009-10
- Completion (planned or actual)
- 2011-07
- Participants
- 263 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin Lispro.
It had two arms (groups): HumaPen Luxura (experimental) and HumaPen Memoir (experimental).
The registry classes the interventions as device and drug.
Who Took Part
Enrollment: 263 actual participants took part.
It was open to people of any sex aged from 8 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes mellitus. Receiving at least 3 prandial injections per day with short-acting or analogue insulin.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: insulin pump therapy; receiving pre-mixed insulin preparations.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Insulin Lispro study did not mask who received what.
It started in 2009-10 with completion listed for 2011-07.
It ran at 29 sites in Germany (29).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint (time frame: Baseline, Week 24).
It also tracked 4 secondary outcomes, for example Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint, 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24 and 30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Lispro in 263 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.