A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia
Phase 1
Withdrawn
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02635243
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544 versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced hypoglycemia.
Secondary Objective:
To assess the safety and tolerability and pharmacokinetics (PK) of a single SC dose of SAR438544 versus recombinant glucagon in T1DM patients under induced hypoglycemia.
- Detailed Description
The total duration of study per patient is up to 8 weeks with 3 to 28 days screening period, 1 day for treatment for both periods and 7 to 14 days wash out between 2 administrations, and 7 days (+/- 1 day) follow-up after last IMP administration.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SAR438544 dose 1 SAR438544 Single dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin\^®R will be used to induce hypoglycemia. SAR438544 dose 1 insulin Single dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin\^®R will be used to induce hypoglycemia. Glucagon r-glucagon Single dose of glucagon given SC under fasting conditions and under induced hypoglycemia. Novolin\^®R will be used to induce hypoglycemia. Glucagon insulin Single dose of glucagon given SC under fasting conditions and under induced hypoglycemia. Novolin\^®R will be used to induce hypoglycemia. SAR438544 Optional Dose insulin Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin\^®R will be used to induce hypoglycemia. SAR438544 Optional Dose SAR438544 Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin\^®R will be used to induce hypoglycemia.
- Primary Outcome Measures
Name Time Method Time to reach a smoothed blood glucose of 70 mg/dL after initial administration of investigational medicinal product Day 1
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half-life 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): Cmax 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 Number of patients with adverse events Day 1 to Day 7 (+/- 1 day) Time to reach a smoothed blood glucose of 90 mg/dL after initial administration of investigational medicinal product Day 1 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 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