Type 2 DiabetesNCT06863532
Efficacy and Safety Comparison of Cofrogliptin Add-on Versus Metformin Dose-escalation in Type 2 Diabetes Patients Inadequately Controlled With SGLT-2 Inhibitors Plus Low-Dose Metformin:A Multicenter, Open-Label Trial
A study testing Cofrogliptin+SGLT2i+Metformin and Metformin dose escalation in people with Type 2 Diabetes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The aim of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cofrogliptin+SGLT2i+Metformin and Metformin dose escalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2025to 1 Sep 2026
- Phase
- Interventional
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign a written informed consent form.
- Male or female aged 18-74 years (inclusive).
- Meet the diagnostic criteria for type 2 diabetes mellitus (T2DM).
- Have initiated treatment with any one of the SGLT2i monotherapy (dapagliflozin 10mg/d, canagliflozin 100mg/d, empagliflozin 10mg/d, ertugliflozin 5mg/day, or henagliflozin 10mg/day) for at least 8 weeks.
- Have received 500-1000mg/day metformin treatment for at least 8 weeks with a stable, unchanged dose maintained during the screening period.
- HbA1c level within the range of 7.5% to 9.5% inclusive.
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- Fasting blood glucose (FBG) level less than 15 mmol/L before randomization.
- Body mass index (BMI) less than or equal to 40 kg/m2 before randomization.
- Urine ketone test negative before randomization.
- Estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73m2 or higher before randomization.
- Agree to maintain the same diet and exercise habits throughout the trial, and be willing and able to correctly use a home blood glucose meter for self-monitoring of blood glucose (SMBG) and keep records.
Who cannot join
- Type 1 diabetes mellitus.
- Various types 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 liver insufficiency of any cause, defined as ALT (SGPT), AST (SGOT), or alkaline phosphatase serum levels greater than 3 times the upper limit of normal (ULN) during the screening period.
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- Acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, unstable angina), stroke, or transient ischemic attack (TIA) within the past 3 months.
- Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 90 mmHg.
- Hemoglobin level less than 10 g/l or 100 mg/dl.
- Recurrent genitourinary infections more than twice within the past 3 months.
- History of bariatric surgery or other gastrointestinal surgeries causing chronic malabsorption within the past 2 years.
- Received anti-obesity medication within the past 3 months or any other treatment (e.g., surgery, radical diet plans) that led to unstable body weight at the time of screening.
- History of cancer (except basal cell carcinoma) and/or cancer treatment within the past 5 years.
- Human immunodeficiency virus (HIV) positivity.
- Severe peripheral vascular disease.
- Hematological malignancies or any diseases causing hemolysis or erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia).
- Coexisting immune system diseases or currently receiving systemic corticosteroid therapy.
- Changes in thyroid hormone dosage within the past 6 weeks, or any other uncontrolled endocrine or metabolic disorders outside of T2DM.
- Alcohol or drug abuse within the past 3 months that may reduce trial compliance, or any chronic illnesses that the investigator believes may lead to reduced trial compliance or reduced use of the study drug.
- Known allergies to components of the study medication or other drugs with similar chemical structures or excipients.
- Pregnant women, women planning to become pregnant during the study, or lactating women. Subjects unwilling to use reliable contraception (including condoms, spermicides, or intrauterine devices) from the time of signing the informed consent form until 28 days after the last administration of the study medication, or women planning to use progesterone-containing contraceptives during this period. Men with fertility plans during the study.
- Participation in any other clinical study within the past 30 days.
- Any other condition deemed unsuitable for participation in this study by the investigator.
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, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Wenheng Zeng, Doctor, +86 137 5711 8319, 42590910@qq.com
Chao Zheng, Doctor
About this study
The aim of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin. Participants will be asked to use either cofrogliptin combined with SGLT2i and metformin or SGLT2i combined with increased dose of metformin.
Read the detailed description
The primary objective of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin.
The secondary objectives of this study are to evaluate the changes in the following parameters (for indicators requiring pre-post comparison, the baseline level during the baseline treatment period is used for comparison):of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin:
- The proportion of subjects with HbA1c < 7.0% and < 6.5% after 24 weeks of treatment.
- Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks of treatment.
- Change in HbA1c levels from baseline after 12 weeks of treatment.
- Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function from baseline after 24 weeks of treatment.
- The proportion of subjects who withdrew due to the need for rescue therapy for hyperglycemia.
- The safety profile of triple therapy with cofrogliptin.
- Conditions
- Type 2 Diabetes
- Being tested
- Cofrogliptin+SGLT2i+Metformin, Metformin dose escalation
- Keywords
- t2dm
- 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.
Cofrogliptin+SGLT2i+MetforminDrug
The cofrogliptin add-on group will continue their existing SGLT2i plus metformin regimen and dosing, with the add-on of cofrogliptin over 24 weeks of triple combined therapy.
Metformin dose escalationDrug
The metformin dose escalation group will have their metformin dose gradually increased to the target dose.
| Study group | Role | What they receive |
|---|---|---|
| cofrogliptin add-on group | Experimental | The cofrogliptin add-on group will continue their existing SGLT2i plus metformin regimen and dosing, with the add-on of cofrogliptin over 24 weeks of triple combined therapy. Receives: Drug: Metformin dose escalation |
| Metformin dose escalation group | Active comparator | The metformin dose escalation group will have their metformin dose gradually increased to the target dose Receives: Drug: Cofrogliptin+SGLT2i+Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in glycated hemoglobin (HbA1c) levels
the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therap
Measured: throughout the study, about 1 year
Secondary outcomes (6)
The proportion of subjects with HbA1c < 7.0% and < 6.5%
The proportion of subjects with HbA1c < 7.0% and < 6.5% after 24 weeks of treatment.
Measured: throughout the study, about 1 year
2h-PPG and FPG
Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks of treatment.
Measured: throughout the study, about 1 year
Change in HbA1c levels
Change in HbA1c levels from baseline after 12 weeks of treatment.
Measured: throughout the study, about 1 year
Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function
Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function from baseline after 24 weeks of treatment.
Measured: throughout the study, about 1 year
proportion of subjects who withdrew
The proportion of subjects who withdrew due to the need for rescue therapy for hyperglycemia.
Measured: throughout the study, about 1 year
The safety profile
The safety profile of triple therapy with cofrogliptin.
Measured: throughout the study, about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital, Hangzhou Hospital of Traditional Chinese Medicine, Wenzhou Central Hospital, The Second Affiliated Hospital of Dalian Medical University
- Responsible party
- Sponsor
- Investigators
- Chao Zheng, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863532
- Sponsor's protocol ID
- 2024-0986
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: medical data should be analyzed before sharing to avoind misunderstanding
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison of Cofrogliptin Add-on Versus Metformin Dose-escalation in Type 2 Diabetes Patients Inadequately Controlled With SGLT-2 Inhibitors Plus Low-Dose Metformin:A Multicenter, Open-Label Trial
- ClinicalTrials.gov ID
- NCT06863532
- Acronym / sponsor ID
- 2024-0986
- Conditions
- Type 2 Diabetes
- Keywords
- t2dm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital, Hangzhou Hospital of Traditional Chinese Medicine, Wenzhou Central Hospital, The Second Affiliated Hospital of Dalian Medical University
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Mar 2025 (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.
The aim of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin. Participants will be asked to use either cofrogliptin combined with SGLT2i and metformin or SGLT2i combined with increased dose of metformin.
Detailed description
The primary objective of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin.
The secondary objectives of this study are to evaluate the changes in the following parameters (for indicators requiring pre-post comparison, the baseline level during the baseline treatment period is used for comparison):of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin:
- The proportion of subjects with HbA1c < 7.0% and < 6.5% after 24 weeks of treatment.
- Changes in 2-hour postprandial plasma glucose (2h-PPG) and fasting plasma glucose (FPG) from baseline at 12 and 24 weeks of treatment.
- Change in HbA1c levels from baseline after 12 weeks of treatment.
- Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function from baseline after 24 weeks of treatment.
- The proportion of subjects who withdrew due to the need for rescue therapy for hyperglycemia.
- The safety profile of triple therapy with cofrogliptin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cofrogliptin add-on group | Experimental | Drug: Metformin dose escalationThe cofrogliptin add-on group will continue their existing SGLT2i plus metformin regimen and dosing, with the add-on of cofrogliptin over 24 weeks of triple combined therapy. |
| Metformin dose escalation group | Active comparator | Drug: Cofrogliptin+SGLT2i+MetforminThe metformin dose escalation group will have their metformin dose gradually increased to the target dose |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to understand and voluntarily sign a written informed consent form.
- Male or female aged 18-74 years (inclusive).
- Meet the diagnostic criteria for type 2 diabetes mellitus (T2DM).
- Have initiated treatment with any one of the SGLT2i monotherapy (dapagliflozin 10mg/d, canagliflozin 100mg/d, empagliflozin 10mg/d, ertugliflozin 5mg/day, or henagliflozin 10mg/day) for at least 8 weeks.
- Have received 500-1000mg/day metformin treatment for at least 8 weeks with a stable, unchanged dose maintained during the screening period.
Key exclusion criteria (23 listed)
- Type 1 diabetes mellitus.
- Various types 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.
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 |
|---|---|---|
| Cofrogliptin+SGLT2i+MetforminThe cofrogliptin add-on group will continue their existing SGLT2i plus metformin regimen and dosing, with the add-on of cofrogliptin over 24 weeks of triple combined therapy. | Drug | Metformin dose escalation group |
| Metformin dose escalationThe metformin dose escalation group will have their metformin dose gradually increased to the target dose. | Drug | cofrogliptin add-on group |
Primary outcome
the change in glycated hemoglobin (HbA1c) levels
Time frame: throughout the study, about 1 year
the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therap
6 secondary outcomes
The proportion of subjects with HbA1c < 7.0% and < 6.5%
Time frame: throughout the study, about 1 year
2h-PPG and FPG
Time frame: throughout the study, about 1 year
Change in HbA1c levels
Time frame: throughout the study, about 1 year
Changes in body weight, fasting C-peptide, insulin sensitivity, and β-cell function
Time frame: throughout the study, about 1 year
proportion of subjects who withdrew
Time frame: throughout the study, about 1 year
The safety profile
Time frame: throughout the study, about 1 year
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 7 Mar 2025.
- Individual participant dataSharing planned: No. medical data should be analyzed before sharing to avoind misunderstanding
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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.
Chao Zheng, Doctor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cofrogliptin+SGLT2i+Metformin and Metformin dose escalation in people with Type 2 Diabetes, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 11 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Wenheng Zeng, Doctor (+86 137 5711 8319, 42590910@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in glycated hemoglobin (HbA1c) levels (time frame: throughout the study, about 1 year). 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 7 Mar 2025.