a study of prusogliptin tablets combined with dapagliflozin tablets and metformin hydrochloride extended release tablets in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study is a multicenter, randomized, double-blind, parallel-controlled, phase iii clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.

avoid duplicating information that will be entered elsewhere, such as eligibility criteria or outcome measures.

Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes was confirmed at least 10 weeks prior to the screening; * male or female, 18 years ≤ age ≤ 75 years; * body mass index (bmi) ≥ 18.5 kg/m\^2, and ≤40 kg/m\^2; * stable metformin therapy for at least 10 weeks prior to screening at a dose ≥ 1500 mg per day; * the glycated hemoglobin must meet the following standards:during screening: 7.5% ≤ hba1c ≤ 11.0% (local laboratory);before random sampling: 7.0% ≤ hba1c ≤ 10.5% (central laboratory); * be able to understand and follow the test procedures, voluntarily participate in the test and sign the icf. exclusion criteria: * type 1 diabetes or other special types of diabetes; * ≥2 episodes of grade 3 hypoglycemia within 6 months prior to screening, or any grade 3 hypoglycemia occurring from screening to randomization; * ≥1 episode of acute diabetic complications (e.g., diabetic ketoacidosis, hyperglycemic hyperosmolar state) within 6 months prior to screening or prior to randomization; * severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot) within 6 months prior to screening; * history of acute or chronic pancreatitis at screening or prior to randomization; * inflammatory bowel disease, partial intestinal obstruction, or chronic intestinal diseases associated with malabsorption within 6 months prior to screening or prior to randomization; * previous gastrointestinal surgeries that may cause malabsorption (excluding polypectomy and appendectomy), or chronic use of medications directly affecting gastrointestinal motility at screening or prior to randomization; * any cardiovascular event within 6 months prior to screening or prior to randomization, including: decompensated heart failure (nyha class iii or iv); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; long qt syndrome or prolonged qtcf interval (male \>450 ms, female \>470 ms); clinically significant arrhythmia requiring treatment and deemed unsuitable for trial participation by the investigator; * hemorrhagic stroke or acute ischemic stroke within 6 months prior to screening or prior to randomization; * acute gallbladder disease within 6 months prior to screening, or active gallbladder disease requiring treatment at screening/prior to randomization; * history of severe psychiatric disorders (e.g., depression, anxiety disorders), severe osteoporosis, or other medical conditions that may endanger participant safety as judged by the investigator; * malignancy (except clinically cured basal cell carcinoma or carcinoma in situ) diagnosed or treated within 5 years prior to screening or prior to randomization; * severe infection or trauma within 4 weeks prior to screening/prior to randomization; recurrent urinary tract infections or genital infections within 6 months prior to screening; or symptomatic urinary/genital infections at screening/prior to randomization; * clinically significant hematologic diseases (e.g., aplastic anemia, myelodysplastic syndrome) or conditions causing hemolysis or erythrocyte instability (e.g., malaria) at screening/prior to randomization; * pregnant or lactating women; * other conditions deemed unsuitable for trial participation by the investigator.