| Trial ID: | L2190 |
| Source ID: | NCT02485327
|
| Associated Drug: |
Technosphere Insulin Sar439065 Afrezza®
|
| Title: |
PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Technosphere Insulin SAR439065 Afrezza®
|
| Outcome Measures: |
Primary: Assessment of PK parameter: area under the serum insulin concentration time curve from time 0 to 8H (INS-AUC0-8H), 8 hours|Assessment of PD parameter: area under the glucose infusion rate curve (GIR) necessary to maintain euglycemia during the euglycemic clamp over 8 hours, 8 hours | Secondary: Assessment of PK parameter: maximum Afrezza insulin serum concentration (INS-Cmax), 8 hours|Assessment of PK parameter: time to INS-Cmax (INS-tmax), 8 hours|Assessment of PD parameter: maximum smoothed GIR (GIRmax), 8 hours|Assessment of PD parameter: time to GIRmax (GIR-Tmax), 8 hours
|
| Sponsor/Collaborators: |
Sponsor: Mannkind Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-07
|
| Completion Date: |
2015-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-15
|
| Locations: |
Investigational Site Number 276001, Mainz, 55116, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02485327
|
