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A Study of HDM1005 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled , phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus placebo in subjects with T2DM inadequate glycemic control with diet and exercise alone. A total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) , then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (placebo), with 80 subjects in each treatment group. At week 36, subjects in placebo group will receive HDM1005 injection until week 52. All treatment groups will implement dose titration to achieve the target dose. The study consists of: up to 2-week screening, 2-week run-in, 36-week core treatment, 16-week extension treatment, and 4-week follow-up, totaling 60 weeks. The end-of-study visit will be conducted 28 days after the last administration cycle.
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled , Phase 3 Study Comparing the Efficacy and Safety of HDM1005 Versus Placebo in Subjects With T2DM Inadequate Glycemic Control With Diet and Exercise Alone
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-02-24
Completion Date
2027-12-17
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
HDM1005 1
administered SC, QW, 52 weeks.
HDM1005 2
administered SC, QW, 52 weeks.
HDM1005 injection or placebo
administered SC, QW, 52 weeks.
Locations (1)
Chinese PLA General Hospital
Beijing, China