Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03436498
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2018-02-12
Brief Title:
Safety Assessment of SAR341402 and NovoLog Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Safety Assessment of SAR341402 and NovoLog Used in Continuous Subcutaneous Insulin Infusion CSII in Adult Patients With Type 1 Diabetes Mellitus T1DM
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
- 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
Detailed Description:
The study duration for each patient will be approximately 10 weeks including a 2-week screening period 2 treatment periods of 4 weeks each and 1-day post-treatment safety follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1200-1241 | OTHER | UTN | None |