Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350890
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-03-27
Brief Title:
Efficacy and Safety of Berberine Ursodeoxycholate HTD1801 in Patients With Type 2 Diabetes
Sponsor:
HighTide Biopharma Pty Ltd
Organization:
HighTide Biopharma Pty Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus Who Have Poor Glycemic Control After Dietary and Exercise Interventions
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
Symphony1
Brief Summary:
The goal of this clinical study 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 3 randomized double-blind placebo-controlled study will evaluate the efficacy and safety of HTD1801 in two phases a 24-week double-blind phase followed by a 28-week open-label extension 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 21 to receive HTD1801 1000 mg twice daily BID or placebo for 24 weeks
Patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for an additional 28 weeks
Patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for an additional 28 weeks
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?:
False
Is an FDA AA801 Violation?:
None