This is a multicenter, randomized, double-blind, active-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets compared with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.
Male or female subjects between 18 and 75 years of age (inclusive).
Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months based on the World Health Organization, and participants treated with a stable dose of metformin (with maintenance dose of at least 1500 mg/day or a maximally tolerated dose not less than 1000 mg) for at least 8 weeks prior to screening; and must be stable for at least 12 weeks prior to randomization.
HbA1c ≥7.5% and ≤11.0% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤11.0% prior to randomization as assessed by the specified central laboratory.
Having a body mass index (BMI) of 19.0 to 40.0 kg/m2, inclusive.
Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus
Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months prior to signing the informed consent form (ICF).
Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2)
History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator)
Parallel
HDM1002 100 mg
DrugHDM1002 tablets, 100 mg once daily, 52 weeks
HDM1002 200 mg
DrugHDM1002 tablets, 200 mg once daily, 52 weeks
HDM1002 400 mg
DrugHDM1002 tablets, 400 mg once daily, 52 weeks
Dapagliflozin (DAPA)
Drugdapagliflozin 10mg will be provided
Change From Baseline in HbA1c at Week 40
HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control
Change From Baseline in HbA1c at Week 52
HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control
Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% with or without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia
The target HbA1c level for people with diabetes is usually less than 7%.
Change From Baseline in Fasting plasma Glucose
The fasting plasma glucose measures the levels of glucose in the blood, with a normal range of 70 mg/dL to 99 mg/dL
Change from baseline in fasting C-peptide and fasting insulin
C-Peptide and Fasting Insulin were measured at planned time points
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