A Phase 2 interventional study of VCT220 tablets and Placebo in Type 2 Diabetes Mellitus (DM), sponsored by Vincentage Pharma Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Vincentage Pharma Co., Ltd · Phase 2, Interventional, and Treatment
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 120 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Vincentage Pharma Co., Ltd is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Any of the following local laboratory or 12-lead electrocardiogram findings during screening:
Drug: VCT220 tablets
Drug: VCT220 tablets
Drug: VCT220 tablets
Drug: Placebo
VCT220 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.
Matching 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
Time frame: Baseline (Week0) and Week 16
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline (Week0) and Week 16
Change From Baseline in Fasting Insulin
Time frame: Baseline (Week0) and Week 16
Change From Baseline in Fasting C Peptide
Time frame: Baseline (Week0) and Week 16
Change From Baseline in 2 Hour Postprandial Plasma Glucose
Time frame: Baseline (Week0) and Week 16
Change From Baseline in 2 Hour Postprandial Insulin
Time frame: Baseline (Week0) and Week 16
Change From Baseline in 2 Hour Postprandial C Peptide
Time frame: Baseline (Week0) and Week 16
Percentage of Participants With HbA1c Below 7%
Time frame: Week 16
Percentage of Participants With HbA1c at or Below 6.5%
Time frame: Week 16
Change From Baseline in Mean 7 Point Self Monitored Blood Glucose
Time frame: Baseline (Week0) and Week 16
Incidence of Adverse Events
Time frame: From enrollment to the end of treatment at week 16
VCT220 Plasma Concentration
Time frame: Week 0、Week 2、Week 4、Week 8、Week 12 and Week 16
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: VCT220
Vincentage Pharma Co., Ltd