Phase 2Not yet recruiting
A Study of VCT220 Tablets in Adults With Type 2 Diabetes and Inadequate Blood Glucose Control (VICTOR-DM)
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VCT220 Tablets in Adults With Type 2 Diabetes Mellitus Inadequately Controlled With Lifestyle Intervention, Metformin Monotherapy, or Metformin in Combination With an SGLT2 Inhibitor
- Sponsor
- Vincentage Pharma Co., Ltd (Industry)
- Enrolment
- 120 planned
- Conditions
- Type 2 Diabetes Mellitus (DM)
- Interventions
- VCT220 tablets; Placebo
- Ages
- adults, older adults
- Registry
- NCT07872436
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change From Baseline in HbA1c
History
Study completion expected
Primary completion expected
Expected to start
Registered