Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03436498 · ClinicalTrials.gov registry record · Phase 1
Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT03436498 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 45 participants.
The verdict
NCT03436498, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
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 \[according to ADA (American Diabetes Association) Workgroup on hypoglycemia\].
Interventions
- DRUG Insulin aspart
- DRUG Insulin aspart SAR341402
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2018-10-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03436498
The ClinicalTrials.gov registry entry for NCT03436498 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Insulin aspart is the first listed.
NCT03436498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03436498 about?
NCT03436498 is a clinical study titled "Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients". 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 hype...
What is the current status of trial NCT03436498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2018-05-10. Estimated completion is 2018-10-06.
What interventions are being tested in trial NCT03436498?
The interventions under investigation include: Insulin aspart (DRUG), Insulin aspart SAR341402 (DRUG).
Who is sponsoring clinical trial NCT03436498?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.