A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

Summary

Primary Objective: To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®. Secondary Objective: To assess the safety and tolerability of SAR341402.

Timeline

Start

2012-11-14

Primary completion

2012-12-28

Completion

2012-12-28

Publications

• Kapitza C, Nosek L, Schmider W, Teichert L, Nowotny I. Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes. Diabetes Technol Ther. 2020 Apr;22(4):278-284. doi: 10.1089/dia.2019.0351. Epub 2019 Dec 30.

Drugs

Indications