| Trial ID: | L5569 |
| Source ID: | NCT05134987
|
| Associated Drug: |
Nnc0363-0845
|
| Title: |
A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes Pharmacokinetics and Pharmacodynamics: How Insulin NNC0363-0845 is Transported Throughout the Body and How It Works
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: NNC0363-0845|DRUG: Insulin detemir
|
| Outcome Measures: |
Primary: AUCPG,0.5-2h Area under the plasma glucose-time curve at steady concentrations, messured in h\*mmol/L, From 0.5 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3) | Secondary: AUCPG,0-1h Area under the plasma glucose-time curve at steady concentrations, messured in h\*mmol/L, From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)|AUCPG,0-2hArea under the plasma glucose-time curve at steady concentrations, messured in h\*mmol/L, From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)|AUCPG,0-4h Area under the plasma glucose-time curve at steady concentrations, messured in h\*mmol/L, From 0 to 4 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)|∆PGav,0-1h Mean change in plasma glucose at steady concentrations, messured in mmol/L, From 0 to 1 hour after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)|∆PGav,0-2h Mean change in plasma glucose at steady concentrations, messured in mmol/L, From 0 to 2 hours after initiation of meal glucose appearance test (visit 4 day 3 and visit 5 day 3)|Number of adverse events, Number of events, From first IMP administration until 16 hours after last IMP administration (visit 4 day 3 and visit 5 day 3)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-12-01
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| Completion Date: |
2022-05-06
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| Results First Posted: |
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| Last Update Posted: |
2022-11-04
|
| Locations: |
Novo Nordisk Investigational Site, Graz, 8010, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT05134987
|
