Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481085
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-13
Brief Title:
To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
Sponsor:
Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd
Organization:
Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo Controlled Parallel Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin or Diet and Exercise
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This is a randomized double-blind placebo controlled parallel group study which aims to provide data on efficacy safety and pharmacokinetics PK of multiple dose levels of HDM1002 tablets in adults with type 2 diabetes mellitus T2DM inadequately controlled on metformin andor diet and exercise
Detailed Description:
This phase 2 multi-center randomized double-blind placebo-controlled parallel group study aims to assess the efficacy and safety of HDM1002 tablets in adult participants with T2DM inadequately controlled on metformin monotherapy or diet and exercise alone At least 80 of the enrolled participants are required to be on metformin prior to screening A total of 318 participants will be included in this study and will be stratified according to baseline glycated hemoglobin HbA1c 85 or 85 and background diabetes treatment metformin or diet and exercise alone For cohort A to cohort E approximately 293 participants will be randomized in a 5757576557 ratio to receive different doses of HDM1002 or placebo In addition an open-label design will be used in cohort F to explore the efficacy and safety of HDM1002 tablets administered in 200 mg twice daily About 25 participants will be enrolled in cohort F all of which will receive HDM1002 tablets Following the screening period to confirm eligibility up to 2-weeks the study will consist of a 2-week placebo run-in period participants with diet and exercise alone or a 6-week metformin run-in period participants with metformin prior to screening prior to randomization on Day 1 The treatment period will be 12 weeks followed by an approximate 4-week follow-up Dosing will occur with or without food once daily or twice daily and up to 4 weeks of dose titration regimen will be adopted to maximize tolerability of HDM1002
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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