NCT02603510

Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion

A Randomized, 2X4 Week, Active-Controlled, Open-Label, 2-Treatment Arm, 2-Period Cross-Over Study Assessing the Safety of SAR342434 and Humalog® 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: 27 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: * Assess the safety of SAR342434 and Humalog when used in external pumps. Secondary Objectives: * Intervals for infusion set changes. * Incidence of insulin pump alarms for infusion set occlusion. * Patient observation of infusion set occlusion. * Adverse events including bruising at the infusion site and injection site reactions.

Detailed description

The study duration for each patient will be approximately 10 weeks.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	SAR342434	Pharmaceutical form:solution Route of administration: subcutaneous
DRUG	insulin lispro	Pharmaceutical form:solution Route of administration: subcutaneous

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-11-11
• Last updated: 2016-05-19

Locations

2 sites across 1 country: United States