| Trial ID: | L4252 |
| Source ID: | NCT02713841
|
| Associated Drug: |
Inhaled Human Insulin (Inh)
|
| Title: |
Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes
|
| Acronym: |
Samba-01
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: inhaled human insulin (INH)|DRUG: sc insulin lispro (LIS)
|
| Outcome Measures: |
Primary: Area under the insulin human / insulin lispro concentration-time curve from 0 to 8 hours (AUCINS,0-8h), 0 to 8 hours|Bioavailability, Relative delivery efficiency (FREL) of inhaled human insulin (INH) compared to s.c. injected insulin lispro (LIS), 0 to 8 hours |
|
| Sponsor/Collaborators: |
Sponsor: Dance Biopharm Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
|
| Start Date: |
2013-05
|
| Completion Date: |
2013-07
|
| Results First Posted: |
|
| Last Update Posted: |
2016-03-21
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT02713841
|
