Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.

Q: What is the NCT07019012 clinical trial studying?

This study is designed to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Q: Who can participate in NCT07019012?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07019012?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes: A Multicenter, Randomized, Open-Label, Active-Controlled, Non-inferiority Trial

Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes. (NCT07019012) is a Phase 4 interventional studying T2DM, sponsored by Huazhong University of Science and Technology. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 170 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused T2DM subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Able to understand and voluntarily sign a written willing to sign a consent form form. - Male or female subjects aged 18 years and above . - Meet the diagnostic criteria for Type 2 Diabetes Mellitus (T2DM). - Have been on initial SGLT2i monotherapy (dapagliflozin) at a dose of 10 mg daily for at least 12 weeks. - Have received metformin treatment for ≥12 weeks, with a stable dose maintained during the screening period (≥1500 mg/day if tolerable or at the maximum tolerated dose (\<1500 mg/day but ≥1000 mg/day), and no dosage adjustment). - HbA1c levels within the range: 7.0% \< HbA1c ≤ 10.0%. - Fasting plasma glucose (FPG) \< 15 mmol/L. - Body Mass Index (BMI) ≤ 40 kg/m2. - Estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml/min/1.73m2. - Agree to maintain the same diet and exercise habits throughout the trial period, willing and able to accurately use a home blood glucose meter for self-monitoring of blood glucose (SMBG) and keep records. Who Should NOT Join This Trial: - Type 1 Diabetes Mellitus. - Any type of secondary diabetes. - Pending or having undergone pancreatic or β-cell transplantation. - History of pancreatitis or pancreatic resection. - Complicated with diabetic ketoacidosis or hyperosmolar coma. - Moderate or severe hepatic insufficiency of any cause. Hepatic insufficiency is defined as screening period levels of ALT (SGPT), AST (SGOT), or alkaline phosphatase serum levels exceeding 3 times the upper limit of normal (ULN). - Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina), stroke, or transient ischemic attack (TIA) within the last 3 months. - Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg. - Hemoglobin levels \< 10 g/l or 100 mg/dl. - More than 2 recurrent genitourinary infections within the last 3 months. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Able to understand and voluntarily sign a written informed consent form. * Male or female subjects aged 18 years and above . * Meet the diagnostic criteria for Type 2 Diabetes Mellitus (T2DM). * Have been on initial SGLT2i monotherapy (dapagliflozin) at a dose of 10 mg daily for at least 12 weeks. * Have received metformin treatment for ≥12 weeks, with a stable dose maintained during the screening period (≥1500 mg/day if tolerable or at the maximum tolerated dose (\<1500 mg/day but ≥1000 mg/day), and no dosage adjustment). * HbA1c levels within the range: 7.0% \< HbA1c ≤ 10.0%. * Fasting plasma glucose (FPG) \< 15 mmol/L. * Body Mass Index (BMI) ≤ 40 kg/m2. * Estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml/min/1.73m2. * Agree to maintain the same diet and exercise habits throughout the trial period, willing and able to accurately use a home blood glucose meter for self-monitoring of blood glucose (SMBG) and keep records. Exclusion Criteria: * Type 1 Diabetes Mellitus. * Any type of secondary diabetes. * Pending or having undergone pancreatic or β-cell transplantation. * History of pancreatitis or pancreatic resection. * Complicated with diabetic ketoacidosis or hyperosmolar coma. * Moderate or severe hepatic insufficiency of any cause. Hepatic insufficiency is defined as screening period levels of ALT (SGPT), AST (SGOT), or alkaline phosphatase serum levels exceeding 3 times the upper limit of normal (ULN). * Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina), stroke, or transient ischemic attack (TIA) within the last 3 months. * Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg. * Hemoglobin levels \< 10 g/l or 100 mg/dl. * More than 2 recurrent genitourinary infections within the last 3 months. * History of bariatric surgery or other gastrointestinal surgeries leading to chronic malabsorption within the last 2 years. * Weight instability due to anti-obesity medication within the last 3 months or any other treatment (such as surgery, aggressive diet plans) at screening. * History of cancer (excluding basal cell carcinoma) and/or cancer treatment within the last 5 years. * Human Immunodeficiency Virus (HIV) infection. * Severe peripheral vascular disease. * Hematological malignancy or any disorder causing hemolysis or erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia). * Concurrent immune system diseases or currently receiving systemic corticosteroid therapy. * Changes in thyroid hormone dosage within the last 6 weeks, or any other uncontrolled endocrine or metabolic disorder outside of T2DM. * Alcohol or drug abuse within the last 3 months that may reduce trial compliance, or any chronic condition deemed by the investigator as likely to reduce study compliance or medication adherence. * Known allergy to the trial medication components or other chemically similar drugs or excipients. * Pregnant women, women planning pregnancy during the study or breastfeeding, subjects unwilling to use reliable contraception (including condoms, spermicides, or intrauterine devices) from signing the informed consent form until 28 days after the last dose of trial medication, or women planning to use progesterone-containing contraceptives during this period. Men with plans for conception during the study. * Participation in any other clinical study within the last 30 days.

Treatments Being Tested

DRUG

SGLT2i+Metformin+Cofrogliptin

The combination of SGLT2i+Metformin+Cofrogliptin

DRUG

SGLT2i+Metformin+Linagliptin

The combination of SGLT2i+Metformin+Linagliptin

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Wuhan University People's Hospital

Wuhan, Hubei, China

Wuhan University People's Hospital

Wuhan, Hubei, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07019012), the sponsor (Huazhong University of Science and Technology), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07019012 clinical trial studying?

This study is designed to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07019012?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07019012?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07019012. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07019012. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.