Comparing cofrogliptin and increased metformin for better diabetes control

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

This study is testing whether adding cofrogliptin to diabetes treatment works better than just increasing the dose of metformin for people with type 2 diabetes who aren't well-controlled on their current medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06863532 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of adding cofrogliptin to existing treatment versus increasing the dose of metformin in patients with type 2 diabetes who are not adequately controlled on SGLT2 inhibitors and low-dose metformin. Participants will be randomly assigned to receive either the combination of cofrogliptin, SGLT2 inhibitors, and metformin or an increased dose of metformin alongside SGLT2 inhibitors. The primary outcome is the change in glycated hemoglobin (HbA1c) levels after 24 weeks, with secondary outcomes including changes in glucose levels and safety assessments. The study aims to provide insights into optimal treatment strategies for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-74 with type 2 diabetes inadequately controlled on SGLT2 inhibitors and low-dose metformin.

Not a fit: Patients with type 2 diabetes who are well-controlled on their current medication regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved glycemic control for patients with type 2 diabetes who struggle with current treatment regimens.

How similar studies have performed: Previous studies have explored similar treatment combinations, but the specific use of cofrogliptin in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Hangzhou, Zhejiang

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Chao Zheng, Doctor — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Wenheng Zeng, Doctor

Conditions Type 2 Diabetes; t2dm