| Trial ID: | L3721 |
| Source ID: | NCT02206568
|
| Associated Drug: |
Ural
|
| Title: |
Pharmacokinetics of Ultra-Rapid-Acting Insulin Lispro (URAL) in Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: URAL
|
| Outcome Measures: |
Primary: Pharmacokinetics of URAL, Area under the serum insulin lispro concentration-time curve from 0-30 minutes after administration, 1 day | Secondary: Onset of appearance of serum insulin lispro, Measurement of time to reach insulin lispro concentration \>30 pmol/L in the serum, 1 day|Number of subjects with adverse events, Assessment of safety and tolerability of URAL, 1 day
|
| Sponsor/Collaborators: |
Sponsor: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. | Collaborators: Profil Institut für Stoffwechselforschung GmbH
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2014-06
|
| Completion Date: |
2014-09
|
| Results First Posted: |
|
| Last Update Posted: |
2020-07-15
|
| Locations: |
Profil Institut fur Stoffwechselforschung GmbH, Neuss, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02206568
|
