NCT02625636

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

A Randomized, Double-blind, Glucagon and Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Single Escalating Doses of SAR438544 Administered by Subcutaneous Route in Healthy Subjects and Patients With Type 1diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients. Secondary Objective: To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.

Detailed description

Healthy subjects: The total duration of study per subject is up to 4.5 weeks with 2 to 21 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration. T1DM patients: The total duration of study per patient is up to 5.5 weeks with 3 to 28 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration. One or more interim analyses may be performed to support decisions for the next steps of the study.

Conditions

• Type 1 Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-12-09
• Last updated: 2016-08-23

Locations

1 site across 1 country: United States