This study will evaluate whether VCT220 tablets improve blood glucose control in adults with type 2 diabetes whose blood glucose remains inadequately controlled with lifestyle intervention alone, metformin alone, or metformin combined with a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The study will also assess safety, tolerability, and how VCT220 is processed by the body.
Approximately 120 participants will be randomly assigned in equal proportions to VCT220 40 mg, 80 mg, 120 mg, or placebo, taken orally once daily for 16 weeks. Higher-dose groups will start at 40 mg and increase the dose in steps. Participation will last approximately 22 weeks, including screening, a placebo run-in period, treatment, and safety follow-up. The main assessment is the change in glycated hemoglobin (HbA1c) from baseline to Week 16.
Male or female participants aged 18 to 65 years, inclusive, at the time of informed consent.
Type 2 diabetes mellitus diagnosed at least 3 months before screening according to the Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 edition), and meeting one of the following: (a) management with diet and exercise alone for at least 3 months before screening; or (b) oral metformin at a stable dose of ≥1500 mg/day or a maximum tolerated dose of ≥1000 mg/day, alone or with an SGLT2 inhibitor at a stable dose, for at least 8 weeks before screening.
HbA1c of 7.5% to 10.5%, inclusive, at screening, as measured by the local laboratory.
Body weight ≥50 kg and body mass index of 19 to 35 kg/m², inclusive.
Previous diagnosis or suspicion of type 1 diabetes, other specific types of diabetes, or secondary diabetes.
Acute complications of diabetes within 6 months before screening, including diabetic ketoacidosis, lactic acidosis, or hyperosmolar hyperglycemic state.
A Level 3 hypoglycemic event or at least three hypoglycemic events within 6 months before screening.
History or current presence of proliferative retinopathy or maculopathy, painful diabetic neuropathy, diabetic foot ulceration, or intermittent claudication.
Parallel
VCT220 tablets
DrugVCT220 tablets will be administered orally once daily for 16 weeks, preferably with the first meal of the day, according to the assigned treatment regimen and protocol-specified titration schedule. Matching placebo tablets will be added as needed to maintain blinding.
Placebo
DrugMatching placebo tablets containing no active ingredient will be administered orally once daily for 16 weeks, preferably with the first meal of the day. The number of tablets will match that used in the active treatment groups at each treatment stage to maintain blinding.
Change From Baseline in HbA1c
Change From Baseline in Fasting Plasma Glucose
Change From Baseline in Fasting Insulin
Change From Baseline in Fasting C Peptide
Change From Baseline in 2 Hour Postprandial Plasma Glucose
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