Ignite Creation Date:
2024-05-06 @ 8:25 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02738151
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2016-03-31
Brief Title:
Efficacy and Safety of Toujeo Versus Tresiba in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drugs GLP-1 Receptor Agonist
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A 24-week Multicenter Randomized Open-Label Parallel-group StudyComparing the Efficacy and Safety of Toujeo and Tresiba in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drugs GLP-1 Receptor Agonist
Status:
COMPLETED
Status Verified Date:
2018-08
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:
BRIGHT
Brief Summary:
Primary Objective
To demonstrate the noninferiority in the efficacy of Toujeo to Tresiba in glycated hemoglobin HbA1c change from Baseline to Week 24
Secondary Objectives
Change From Baseline in HbA1c to Week 12
To assess the effects of the insulin Toujeo in comparison with insulin Tresiba at week 12 and week 24 on
Change in Fasting plasma glucose FPG
Change in Fasting self-monitored plasma glucose SMPG and 4-point SMPG and 8-point SMPG profile
Percentage of participants reaching HbA1c targets 7 or 65
Percentage of participants reaching HbA1c targets 7 or 65 without severe andor confirmed hypoglycemia
Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association ADA category of hypoglycemia
To assess the safety in each treatment group
To assess the treatment effects in each treatment group on Patient Reported Outcomes PRO
Percentage of participants requiring rescue therapy
To demonstrate the noninferiority in the efficacy of Toujeo to Tresiba in glycated hemoglobin HbA1c change from Baseline to Week 24
Secondary Objectives
Change From Baseline in HbA1c to Week 12
To assess the effects of the insulin Toujeo in comparison with insulin Tresiba at week 12 and week 24 on
Change in Fasting plasma glucose FPG
Change in Fasting self-monitored plasma glucose SMPG and 4-point SMPG and 8-point SMPG profile
Percentage of participants reaching HbA1c targets 7 or 65
Percentage of participants reaching HbA1c targets 7 or 65 without severe andor confirmed hypoglycemia
Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association ADA category of hypoglycemia
To assess the safety in each treatment group
To assess the treatment effects in each treatment group on Patient Reported Outcomes PRO
Percentage of participants requiring rescue therapy
Detailed Description:
The maximum study duration per participant was approximately 27 weeks an up to 2-week screening period a 24-week randomized treatment period including 12 weeks active titration and a 7-day posttreatment safety follow-up 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 |
|---|---|---|---|
| 2015-005101-36 | EUDRACT_NUMBER | None | None |
| U1111-1177-6327 | OTHER | UTN | None |