Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 7:56 AM
Study NCT ID:
NCT04022993
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2019-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients
Sponsor:
Geropharm
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Insulin RinGlar® ("Geropharm", Russia) Compared to Lantus® SoloStar® ("Sanofi-Aventis Deutschland GmbH", Germany) in Type 1 Diabetes Mellitus Patients
Status:
COMPLETED
Status Verified Date:
2019-01
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:
The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: