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

Type 1 Diabetes Mellitus Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02603510
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date November 2015
Completion date April 2016
View Details
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