Ignite Creation Date:
2024-05-06 @ 9:22 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02967211
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2016-11-16
Brief Title:
A Real World Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to Standard of Care Basal Insulin in Patients Already Using Basal Insulin
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Twenty-six Week Randomized Open-label 2-arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Transition to Toujeo Compared to Standard of Care Insulin in Basal Insulin Treated Patients With Uncontrolled Type 2 Diabetes Mellitus With Six-Month Extension
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:
REGAIN CONTROL
Brief Summary:
Primary Objective
To demonstrate noninferiority of Toujeo versus standard of care basal insulin therapy as measured by glycated hemoglobin HbA1c change
Secondary Objectives
To demonstrate superiority of Toujeo versus standard of care basal insulin if non-inferiority criterion is met measured by HbA1c change
To compare Toujeo to other standard of care basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification
Risk of hypoglycemia including documented symptomatic hypoglycemia 70 mgdL or severe according to ADA Working Group
Change in fasting plasma glucose FPG
Change in body weight
Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions DTSQs and DTSQc
Change in hypoglycemic control subscale HCS
Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs
To demonstrate noninferiority of Toujeo versus standard of care basal insulin therapy as measured by glycated hemoglobin HbA1c change
Secondary Objectives
To demonstrate superiority of Toujeo versus standard of care basal insulin if non-inferiority criterion is met measured by HbA1c change
To compare Toujeo to other standard of care basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification
Risk of hypoglycemia including documented symptomatic hypoglycemia 70 mgdL or severe according to ADA Working Group
Change in fasting plasma glucose FPG
Change in body weight
Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions DTSQs and DTSQc
Change in hypoglycemic control subscale HCS
Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs
Detailed Description:
The total study duration will be up to 55 weeks consisting of a 1 week screening period at the site a 26 week treatment period and a 26 week extension period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| U1111-1170-8132 | OTHER | UTN | None |
| 2015-001832-39 | EUDRACT_NUMBER | None | None |