Ignite Creation Date:
2024-05-06 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03406000
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2018-01-15
Brief Title:
Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 UmL
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A 28-week Prospective Single-arm Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 UmL in Combination With Prandial Rapid-acting Insulin Analogue in Patients With Type 1 Diabetes Previously Uncontrolled on Twice-daily Basal Insulin as Part of Basal-bolus Therapy
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:
TOP1
Brief Summary:
Primary Objective
To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine U300 as part of basal bolus regime in terms of glycated hemoglobin improvement reduction by at least 03 in uncontrolled type 1 diabetes mellitus patients
Secondary Objectives
To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events weight changes and adverse events
To evaluate the effect of insulin glargine U300 on diabetes treatment satisfaction and fear of hypoglycemia as well as patients satisfaction regarding the number of daily injections
To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine U300 as part of basal bolus regime in terms of glycated hemoglobin improvement reduction by at least 03 in uncontrolled type 1 diabetes mellitus patients
Secondary Objectives
To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events weight changes and adverse events
To evaluate the effect of insulin glargine U300 on diabetes treatment satisfaction and fear of hypoglycemia as well as patients satisfaction regarding the number of daily injections
Detailed Description:
The estimated average study duration is 29 weeks including run-in period of 4 weeks treatment period of 24 weeks and follow-up period of 1 week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1186-2485 | OTHER | UTN | None |