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

NCT02603510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-05-19

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

SAR342434

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

insulin lispro

Pharmaceutical form:solution Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02603510 on ClinicalTrials.gov