NCT07193459

Study to Evaluate HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	HDM1002 200 mg	HDM1002 tablets, 200 mg once daily
DRUG	HDM1002 400 mg	HDM1002 tablets, 400 mg once daily
DRUG	Placebo	Placebo tablets, once daily

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-10-10
• Completion: 2027-02-01
• First posted: 2025-09-25
• Last updated: 2025-09-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study