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

• Status: Completed
• Trial end date: 2018-10-06

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].

• Phase: Phase 1

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting