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

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: SAR342434; Drug: insulin lispro

• Registration Number: NCT02603510
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SAR342434/Humalog	insulin lispro	SAR342434 and Humalog will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
Humalog/SAR342434	SAR342434	Humalog and SAR342434 will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
SAR342434/Humalog	SAR342434	SAR342434 and Humalog will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.
Humalog/SAR342434	insulin lispro	Humalog and SAR342434 will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion.

Primary Outcome Measures

Name	Time	Method
Frequency of infusion set occlusions	4 weeks

Secondary Outcome Measures

Name	Time	Method
Number of infusion set changes in each treatment period	4 weeks
Number of adverse events	4 weeks
Number of insulin pump alarms for infusion set occlusions	4 weeks

Trial Locations

Locations (2)

Investigational Site Number 840002; 🇺🇸 Little Rock, Arkansas, United States

Investigational Site Number 840001; 🇺🇸 Denver, Colorado, United States