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Study identifier: NCT07394114 Synced from ClinicalTrials.gov · July 28, 2026
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A Study of HDM1005 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

Condition: Type 2 Diabetes  ·  Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

PhasePhase 3
Planned participants240
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Wenyan Cao  ·  +86 18810614389  ·  cxycaowenyan@eastchinapharm.com

Always discuss trial participation with your own doctor first.

Locations (1)

Chinese PLA General HospitalBeijing, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07394114