Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT05760456
Status:
UNKNOWN
Last Update Posted:
2023-03-08
First Post:
2023-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.
Sponsor:
Centre of Clinical Pharmacology, Hanoi Medical University
Organization:
Study Overview
Official Title:
An Open-label, Randomized, Parallel-controlled Study to Evaluate the Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
NOT_YET_RECRUITING
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:
This is an open-label, two-group parallel study, comparing before and after treatment within the same group and between the two groups. This study is designed to collect data on the safety and efficacy of a marketed pharmaceutical product (DIDALA) compared with Metformin. The efficacy data of DIDALA will be directly compared with Metformin 1000mg/day monotherapy in this study.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: