This study is a multicenter, randomized, double-blind (with open-label dose levels and active comparator), parallel-group, placebo- and active-controlled Phase 2 clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic (PK) characteristics of HDM1005 in subjects with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control after diet/exercise or metformin therapy.
A total of 216 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) and prior metformin use, then randomized 1:1:1:1:1:1 to: Group 1 (HDM1005 0.5 mg), Group 2 (HDM1005 1.0 mg), Group 3 (HDM1005 2.0 mg), Group 4 (HDM1005 3.0 mg), Group 5 (Placebo), and Group 6 (open-lable dulaglutide 1.5 mg, active comparator), with 36 subjects in each treatment group. Within each dose cohort (0.5/1.0/2.0/3.0mg), there will be \~45 total subjects (36 HDM1005 + 9 placebo). The 1.0mg, 2.0mg, and 3.0mg cohorts will implement dose titration.
The study consists of: 2-week screening, 20-week treatment, and 4-week safety follow-up. The end-of-study visit will be conducted 28 days after the last administration cycle.
Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 24 weeks;
Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%
Body Mass Index (BMI within the range of 22.5 ~ 40.0 kg/m2
Other types of diabetes besides T2DM
Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF)
History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF
History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2)
Parallel
HDM1005 1
Drugadministered SC, QW, 20 weeks
HDM1005 2
Drugadministered SC, QW, 20 weeks
HDM1005 3
Drugadministered SC, QW, 20 weeks
HDM1005 4
Drugadministered SC, QW, 20 weeks
Placebo
Drugadministered SC, QW, 20 weeks
Dulaglutide 1.5 MG
Drugadministered SC, QW, 20 weeks
6
Treatment groupsSee each treatment group below.
Change 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.
Change from baseline in HbA1c
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0%
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Change frome baseline in fasting plasma glucose (FPG)
FPG is a test to determine sugar levels in serum sample after an overnight fast.
Change from baseline in body weight
Change from baseline in body weight is calculated by subtracting the baseline weight measurement from the post-treatment weight measurement at a specified time point.
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