NCT03436498

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

Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion (CSII) in Adult Patients With Type 1 Diabetes Mellitus (T1DM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[according to ADA (American Diabetes Association) Workgroup on hypoglycemia\].

Detailed description

The study duration for each patient will be approximately 10 weeks, including a 2-week screening period, 2 treatment periods of 4 weeks each, and 1-day post-treatment safety follow-up period.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin aspart SAR341402	Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUG	Insulin aspart	Pharmaceutical form: Solution Route of administration: Subcutaneous

Timeline

• Start date: 2018-05-10
• Primary completion: 2018-10-06
• Completion: 2018-10-06
• First posted: 2018-02-19
• Last updated: 2022-04-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study