| Trial ID: | L4576 |
| Source ID: | NCT02625636
|
| Associated Drug: |
Sar438544
|
| Title: |
A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: SAR438544|DRUG: placebo|DRUG: r-glucagon
|
| Outcome Measures: |
Primary: Number of patients with adverse events, Day 1 to Day 7 (+/- 1 day) | Secondary: Assessment of PD parameter: continuous monitoring of blood glucose levels over a period of 6 hours post-dose, Day 1|Assessment of PD parameter: area under plasma concentration of the BG-time curve between investigational medicinal product (IMP) dosing and time t (BG-AUC0-t), Day 1|Assessment of PD parameter: BG-maximum concentration (BG-Cmax), Day 1|Assessment of PD parameter: BG-time to Cmax (BG-tmax), Day 1|Assessment of PK parameter (recombinant glucagon and SAR438544): Cmax, Day 1|Assessment of PK parameter (recombinant glucagon and SAR438544): tmax, Day 1|Assessment of PK parameter (recombinant glucagon and SAR438544): tlast, Day 1|Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half life, Day 1|Assessment of PK parameter (recombinant glucagon and SAR438544): area under curve from zero time until the last measurable concentration (AUClast), Day 1|Assessment of PK parameter (recombinant glucagon and SAR438544): AUC, Day 1|Assessment of PK parameter (recombinant glucagon and SAR438544): partial AUCs (AUC0-t), Day 1
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2015-12
|
| Completion Date: |
2016-02
|
| Results First Posted: |
|
| Last Update Posted: |
2016-08-23
|
| Locations: |
Investigational Site Number 840001, Chula Vista, California, 91911, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02625636
|
