NCT07082114

A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

A Phase 3, Randomized, Double-blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets Compared With Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (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, active-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets compared with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.

Detailed description

This phase 3, multi-center, randomized, double-blind, active-controlled, parallel group study aims to assess the efficacy and safety of HDM1002 tablets in adult participants with T2DM inadequately controlled on metformin monotherapy. A total of 800 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 4-week metformin run-in period prior to randomization on Day 1. Eligible participants will be randomized in a 1:1:1:1 ratio to receive different doses of HDM1002 or dapagliflozin 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 100 mg	HDM1002 tablets, 100 mg once daily, 52 weeks
DRUG	HDM1002 200 mg	HDM1002 tablets, 200 mg once daily, 52 weeks
DRUG	HDM1002 400 mg	HDM1002 tablets, 400 mg once daily, 52 weeks
DRUG	Dapagliflozin (DAPA)	dapagliflozin 10mg will be provided

Timeline

• Start date: 2025-07-14
• Primary completion: 2027-02-16
• Completion: 2027-05-17
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study