Actively Recruiting
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
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-03-07
80
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
N
Ningbo Medical Center Lihuili Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign a written informed consent form.
- Male or female aged 18-74 years (inclusive).
- Diagnosed with type 2 diabetes mellitus.
- Have been on SGLT2 inhibitor monotherapy (specific drugs and doses) for at least 8 weeks.
- Have received 500-1000 mg/day metformin for at least 8 weeks with stable dose during screening.
- HbA1c level between 7.5% and 9.5% inclusive.
- Fasting blood glucose less than 15 mmol/L before randomization.
- Body mass index (BMI) less than or equal to 40 kg/m2 before randomization.
- Negative urine ketone test 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 during the trial.
- Willing and able to correctly use a home blood glucose meter for self-monitoring and keep records.
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus.
- Secondary types of diabetes.
- Pending or past pancreatic or beta-cell transplantation.
- History of pancreatitis or pancreatic surgery.
- Diabetic ketoacidosis or hyperosmolar coma.
- Moderate or severe liver insufficiency (ALT, AST, or alkaline phosphatase > 3 times upper limit of normal).
- Acute coronary syndrome, stroke, or transient ischemic attack within past 3 months.
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥90 mmHg).
- Hemoglobin less than 10 g/l or 100 mg/dl.
- Recurrent genitourinary infections more than twice in past 3 months.
- History of bariatric or gastrointestinal surgery causing malabsorption within past 2 years.
- Use of anti-obesity medication within past 3 months or other treatments causing unstable body weight.
- History of cancer (except basal cell carcinoma) or cancer treatment within past 5 years.
- HIV positive.
- Severe peripheral vascular disease.
- Hematological malignancies or diseases causing hemolysis or erythrocyte instability.
- Immune system diseases or current systemic corticosteroid therapy.
- Recent changes in thyroid hormone dosage or uncontrolled endocrine/metabolic disorders other than type 2 diabetes.
- Alcohol or drug abuse in past 3 months or chronic illnesses reducing compliance.
- Known allergies to study drugs or similar compounds.
- Pregnant, planning pregnancy, or breastfeeding; unwilling to use reliable contraception during and 28 days after study medication.
- Participation in another clinical study within past 30 days.
- Any other condition the investigator deems unsuitable for participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Wenheng Zeng, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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