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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
administered SC, QW, 52 weeks.
administered SC, QW, 52 weeks.
administered SC, QW, 52 weeks.
Chinese PLA General Hospital
Beijing, China
RECRUITINGChange from baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
Time frame: Baseline, Week 36
Change from baseline in HbA1c
Time frame: Baseline, Week 52
The percentage of patients reaching the HbA1c targets of <7.0%, ≤6.5%, and <5.7%
Time frame: Week 36, Week 52
Change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline, Week 36, Week 52
Change from baseline in body weight
Time frame: Baseline, Week 36, Week 52
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