Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-25 @ 6:41 PM
Study NCT ID:
NCT07193459
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
Sponsor:
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 3, 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 With Diet and Exercise Only
Status:
RECRUITING
Status Verified Date:
2025-09
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 multicenter, randomized, double-blind, placebo-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise only
Detailed Description:
This phase 3, 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 with diet and exercise only. A total of 360 participants will be randomized in this study, and will be stratified according to baseline glycated hemoglobin (HbA1c) (≤ 8.5% or \> 8.5%). Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a 2-week placebo run-in period prior to randomization on Day 1. Eligible participants will be randomized in a 1:1:1 ratio to receive different doses of HDM1002 or placebo once daily for 52 weeks, followed by an approximate 4-week follow-up. During the treatment period, dose escalation will occur every 4 weeks until the target dose is reached. The evaluation of the primary endpoint will be conducted at Week 40
Study Oversight
Has Oversight DMC:
False
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?: