This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise only
Male or female subjects between 18 and 75 years of age (inclusive).
Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 10 weeks based on the World Health Organization, and meet the following conditions:a) had been treated with diet and exercise for at least 10 weeks prior to signing ICF; b) Not been treated with any hypoglycemic drugs within 10 weeks prior to signing ICF.
HbA1c ≥7.5% and ≤10.5% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤10.5% prior to randomization as assessed by the specified central laboratory.
Having a body mass index (BMI) of 22.5 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 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 200 mg
DrugHDM1002 tablets, 200 mg once daily
HDM1002 400 mg
DrugHDM1002 tablets, 400 mg once daily
Placebo
DrugPlacebo tablets, once daily
Change From Baseline in HbA1c at Week 40
Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia
Change from baseline in body weight, body mass index (BMI), and waist circumference
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg
Percentage of Participants Achieving Weight Loss ≥ 5% and ≥ 10%
Change From Baseline in Fasting plasma Glucose, fasting C-peptide and fasting insulin
The fasting plasma glucose measures the levels of glucose in the blood, with a normal range of 70 mg/dL to 99 mg/dL;C-Peptide and Fasting Insulin were measured at planned time points
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