drugset
drugset / Trial / 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

NCT02625636 ↗

Phase 1 Completed 20 enrolled Sanofi
RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

Start
2015-12
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SAR438544 Unknown — Subcutaneous
Comparator rGlucagon Unknown — Subcutaneous

Indications

type 1 diabetes mellitus