| Trial ID: | L1962 |
| Source ID: | NCT03981627
|
| Associated Drug: |
Ado09 Formulation
|
| Title: |
A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: ADO09 formulation|DRUG: NovoRapid®
|
| Outcome Measures: |
Primary: ΔAUCPG(0-4h), Incremental area under the plasma glucose concentration-time curve from 0-4 hours after start of breakfast, assessed by Super GL at day 24., From 0 to 4 hours | Secondary: Pharmacokinetics of pramlintide, Area under the pramlintide concentration-time curve, From 0 to 4 hours|Pharmacokinetics of insulins, Area under the insulins concentration-time curve, From 0 to 4 hours|Plasma glucose control as measured by CGM, Time and percentage of time in Range (TiR) \[70-180\] mg/dL, Over 24 hours|Safety and tolerability (Adverse Events recording), Number of Adverse Events, Up to 24 days
|
| Sponsor/Collaborators: |
Sponsor: Adocia
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-06-06
|
| Completion Date: |
2020-06-27
|
| Results First Posted: |
|
| Last Update Posted: |
2020-11-30
|
| Locations: |
Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03981627
|
