| Trial ID: | L3878 |
| Source ID: | NCT02603510
|
| Associated Drug: |
Sar342434
|
| Title: |
Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: SAR342434|DRUG: insulin lispro
|
| Outcome Measures: |
Primary: Frequency of infusion set occlusions, 4 weeks | Secondary: Number of infusion set changes in each treatment period, 4 weeks|Number of insulin pump alarms for infusion set occlusions, 4 weeks|Number of adverse events, 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
27
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-11
|
| Completion Date: |
2016-04
|
| Results First Posted: |
|
| Last Update Posted: |
2016-05-19
|
| Locations: |
Investigational Site Number 840002, Little Rock, Arkansas, 72205, United States|Investigational Site Number 840001, Denver, Colorado, 80262, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02603510
|
