NCT02635243

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

SAR438544 - Clinical & Exploratory Pharmacology

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SAR438544	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	r-glucagon	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	insulin	Pharmaceutical form:solution Route of administration: intravenous

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-12-18
• Last updated: 2016-09-02