Type 2 Diabetes Mellitus (DM)Phase 2VICTOR-DMNCT07872436
A Study of VCT220 Tablets in Adults With Type 2 Diabetes and Inadequate Blood Glucose Control
A Phase 2 study testing VCT220 tablets in people with Type 2 Diabetes Mellitus (DM), run by Vincentage Pharma Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (DM)
- What is being tested?
- VCT220 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Self-reported or documented body weight change of no more than 5% within the 3 months before screening.
- Willing and able to maintain a stable residence, remain contactable, and maintain a regular daily routine and diet and exercise management throughout the study.
- Fully understands the study procedures, can communicate effectively with the investigator, understands and can comply with study requirements, and is willing to sign the informed consent form.
Who cannot join
- 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.
- A hematologic disorder or other condition at screening that may affect HbA1c measurement, including known hemoglobinopathy, hemolytic anemia, sickle cell anemia, blood transfusion within 3 months before screening, or severe blood loss within that period.
- Any of the following local laboratory or 12-lead electrocardiogram findings during screening:
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- Fasting plasma glucose >11.1 mmol/L.
- Thyroid-stimulating hormone >6.0 mIU/L or <0.4 mIU/L.
- Alanine aminotransferase or aspartate aminotransferase ≥2 times the upper limit of normal (ULN), or total bilirubin ≥2 × ULN.
- Fasting triglycerides >5.65 mmol/L.
- Serum amylase or lipase ≥1.5 × ULN.
- Estimated glomerular filtration rate <60 mL/min/1.73 m².
- Calcitonin ≥50 ng/L.
- Hemoglobin <110 g/L in males or <100 g/L in females.
- Electrocardiographic heart rate <55 or >110 beats/minute.
- Second- or third-degree atrioventricular block, long QT syndrome, QTcF >450 ms in males or >470 ms in females, left bundle branch block, complete right bundle branch block, pre-excitation syndrome, or other clinically significant arrhythmia, except asymptomatic sinus arrhythmia.
- Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- History or current presence of severe gastrointestinal disease or relevant surgery, including acute or chronic pancreatitis, hepatitis, cholecystitis (except after cholecystectomy), or intestinal obstruction.
- Heart failure of New York Heart Association Class III or IV, unstable angina, stroke, myocardial infarction, or coronary revascularization within 6 months before screening; or planned coronary, carotid, or peripheral arterial revascularization at screening.
- Acute infection within 2 weeks before screening.
- Any malignancy within the previous 5 years or currently, except cured basal cell carcinoma of the skin or cervical carcinoma in situ.
- History or current presence of a condition that may require repeated or long-term systemic glucocorticoid therapy, such as systemic lupus erythematosus, inflammatory bowel disease, or asthma. Topical, intraocular, and intranasal glucocorticoids are excluded from this restriction.
- Known or suspected allergy to VCT220 tablets, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or excipients.
- Previous discontinuation of a GLP-1 RA because of safety or tolerability concerns.
- Insulin treatment within 3 months before screening, or treatment with any glucose-lowering medication other than metformin or an SGLT2 inhibitor during that period, including traditional Chinese medicines used to lower blood glucose.
- Positive hepatitis B surface antigen at screening, except when quantitative hepatitis B virus DNA is below the lower limit of the assay reference range and the participant is not receiving anti-hepatitis B medication at screening; or positive hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis antibody.
- Significantly active or unstable major depressive disorder or another severe psychiatric disorder within 2 years before screening, or any history of attempted suicide.
- History of alcohol or drug abuse within 3 months before screening. Alcohol abuse is defined as more than 7 units per week; one unit is 360 mL of beer containing 5% alcohol, 45 mL of spirits containing 40% alcohol, or 150 mL of wine containing 12% alcohol.
- Treatment with any other investigational product within 3 months or 5 half-lives before screening, whichever is longer, or plans to participate in another clinical trial during this study.
- Pregnancy or breastfeeding; a male or female participant of reproductive potential unwilling to use highly effective contraception throughout the study and for 3 months after the last dose; plans to conceive or donate sperm or oocytes during that period; or a positive pregnancy test during screening.
- An employee of the sponsor, a study site, or the contract research organization, or an immediate family member of such an employee.
- Considered unsuitable for study participation by the study site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Linong Ji, +86-1088324516, jiln@bjmu.edu.cn
About this study
Official title: 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
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.
- Conditions
- Type 2 Diabetes Mellitus (DM)
- Being tested
- VCT220 tablets, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCT220 tabletsDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| VCT220 40 mg | Experimental | Not described Receives: Drug: VCT220 tablets |
| VCT220 80mg | Experimental | Not described Receives: Drug: VCT220 tablets |
| VCT220 120mg | Experimental | Not described Receives: Drug: VCT220 tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c
Measured: Baseline (Week0) and Week 16
Secondary outcomes (11)
Change From Baseline in Fasting Plasma Glucose
Measured: Baseline (Week0) and Week 16
Change From Baseline in Fasting Insulin
Measured: Baseline (Week0) and Week 16
Change From Baseline in Fasting C Peptide
Measured: Baseline (Week0) and Week 16
Change From Baseline in 2 Hour Postprandial Plasma Glucose
Measured: Baseline (Week0) and Week 16
Change From Baseline in 2 Hour Postprandial Insulin
Measured: Baseline (Week0) and Week 16
Change From Baseline in 2 Hour Postprandial C Peptide
Measured: Baseline (Week0) and Week 16
Percentage of Participants With HbA1c Below 7%
Measured: Week 16
Percentage of Participants With HbA1c at or Below 6.5%
Measured: Week 16
Change From Baseline in Mean 7 Point Self Monitored Blood Glucose
Measured: Baseline (Week0) and Week 16
Incidence of Adverse Events
Measured: From enrollment to the end of treatment at week 16
VCT220 Plasma Concentration
Measured: Week 0、Week 2、Week 4、Week 8、Week 12 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vincentage Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872436
- Sponsor's protocol ID
- VCT220-II-01
- Acronym
- VICTOR-DM
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07872436
- Acronym / sponsor ID
- VICTOR-DM / VCT220-II-01
- Conditions
- Type 2 Diabetes Mellitus (DM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vincentage Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VCT220 40 mg | Experimental | Drug: VCT220 tablets |
| VCT220 80mg | Experimental | Drug: VCT220 tablets |
| VCT220 120mg | Experimental | Drug: VCT220 tablets |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Self-reported or documented body weight change of no more than 5% within the 3 months before screening.
Key exclusion criteria (33 listed)
- 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.
- A hematologic disorder or other condition at screening that may affect HbA1c measurement, including known hemoglobinopathy, hemolytic anemia, sickle cell anemia, blood transfusion within 3 months before screening, or severe blood loss within that period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VCT220 tabletsVCT220 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. | Drug | VCT220 120mg, VCT220 40 mg, VCT220 80mg |
| PlaceboMatching 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. | Drug | Placebo |
Primary outcome
Change From Baseline in HbA1c
Time frame: Baseline (Week0) and Week 16
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VCT220 tablets in people with Type 2 Diabetes Mellitus (DM), run by Vincentage Pharma Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miles Zhang (86+18210070401, bd@vincentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in HbA1c (time frame: Baseline (Week0) and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.