NCT06481085

To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 and/or 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) (≤ 8.5% or \> 8.5%) and background diabetes treatment (metformin or diet and exercise alone). For cohort A to cohort E, approximately 293 participants will be randomized in a 57:57:57:65:57 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	HDM1002 50 mg	HDM1002 tablets, 50 mg once daily, 12 weeks
DRUG	HDM1002 100 mg	HDM1002 tablets, 100 mg once daily, 12 weeks
DRUG	HDM1002 200 mg	HDM1002 tablets, 200 mg once daily, 12 weeks
DRUG	HDM1002 400 mg	HDM1002 tablets, 400 mg once daily, 12 weeks
DRUG	HDM1002 200 mg BID	HDM1002 tablets, 200 mg twice daily, 12 weeks
DRUG	Placebo	Matching placebo will be provided

Timeline

• Start date: 2024-06-27
• Primary completion: 2025-05-30
• Completion: 2025-06-30
• First posted: 2024-07-01
• Last updated: 2025-07-28

Locations

31 sites across 1 country: China

Regulatory

• FDA-regulated drug study