Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients

Summary

Primary Objective: \- To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms of the number of patients with infusion set occlusions. Secondary Objectives: * To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of unexplained hyperglycemia. * To assess the safety of SAR341402 and NovoLog® when used in external pumps in terms of: * Intervals for infusion set changes. * Number of patients with insulin pump for "non-delivery" alarm. * Patient observation of infusion set occlusion. * Adverse events and serious adverse events. * Number of patients with hypoglycemic events \[according to ADA (American Diabetes Association) Workgroup on hypoglycemia\].

Timeline

Start

2018-05-10

Primary completion

2018-10-06

Completion

2018-10-06

Publications

• Results Thrasher J, Polsky S, Hovsepian L, Nowotny I, Pierre S, Bois De Fer B, Bhargava A, Mukherjee B, Garg SK. Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial. Diabetes Technol Ther. 2020 Sep;22(9):666-673. doi: 10.1089/dia.2019.0446. Epub 2020 Jan 28.

Drugs

Indications