Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411275
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
A Phase 2 Study of Berberine Ursodeoxycholate HTD1801 in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise
Sponsor:
HighTide Biopharma Pty Ltd
Organization:
HighTide Biopharma Pty Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus T2DM Inadequately Controlled With Diet and Exercise
Status:
COMPLETED
Status Verified Date:
2024-05
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 trial is to evaluate the efficacy and safety of berberine ursodeoxycholate HTD1801 compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone
Detailed Description:
This Phase 2 randomized double-blind placebo-controlled trial will evaluate the efficacy and safety of HTD1801 compared to placebo after 12-weeks of treatment
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 be randomized 111 to receive HTD1801 500 mg twice daily BID HTD1801 1000 mg BID or placebo BID
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 be randomized 111 to receive HTD1801 500 mg twice daily BID HTD1801 1000 mg BID or placebo BID
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