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AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study
Plain-language guide to NCT05184868: phase 1 randomized trial of Insulin Aspart, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05184868
- Phase
- phase 1
- Status
- completed
- Start
- 2022-01-03
- Completion (planned or actual)
- 2022-09-09
- Participants
- 24 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Aspart.
It had three arms (groups): AT247 (experimental), NovoLog® (active comparator) and Fiasp® (active comparator).
The registry classes the interventions as drug.
Who Took Part
24 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: Subjects diagnosed with T1DM for at least 12 months. BMI within the range ≥18.5 - ≤28.0 kg/m2.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imp or related products.
How the Study Was Run
The set-up was randomized, crossover and quadruple-blind.
Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.
Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2022-01-03 with completion listed for 2022-09-09.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Area under Curve for serum insulin (time frame: 0-30 minutes). Area under Curve for Glucose Infusion Rate (time frame: 0-60 minutes).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Aspart in 24 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 Aspart compound page, all human trials.
Our Notes on the Compound
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.