Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415773
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Brief Title:
Effects of Berberine Ursodeoxycholate HTD1801 Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
Sponsor:
HighTide Biopharma Pty Ltd
Organization:
HighTide Biopharma Pty Ltd
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Active-Controlled Dapagliflozin Parallel Group Efficacy and Safety Study of HTD1801 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate HTD1801 compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone
Detailed Description:
This Phase 3 randomized double-blind active-controlled parallel-group study will evaluate the efficacy and safety of HTD1801 compared to dapagliflozin after 24 weeks of treatment All patients will remain on a stable dose of metformin throughout the study
To ensure stabilization of glycemic control eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification concomitant medications and procedures for self-monitoring of blood glucose Following this period patient eligibility will be reassessed Eligible patients will then be randomized 11 to receive HTD1801 1000 mg BID or dapagliflozin 10 mg QD
To ensure stabilization of glycemic control eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification concomitant medications and procedures for self-monitoring of blood glucose Following this period patient eligibility will be reassessed Eligible patients will then be randomized 11 to receive HTD1801 1000 mg BID or dapagliflozin 10 mg QD
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?:
None