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

NCT03436498 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-04-25

No results posted yet for this study

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

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin aspart SAR341402

Pharmaceutical form: Solution Route of administration: Subcutaneous

DRUG

Insulin aspart

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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-10
Primary Completion
2018-10-06
Completion
2018-10-06
FDA Drug
Yes

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 NCT03436498 on ClinicalTrials.gov