Actively Recruiting
Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.
Led by Huazhong University of Science and Technology · Updated on 2025-06-13
170
Participants Needed
2
Research Sites
74 weeks
Total Duration
On this page
Sponsors
H
Huazhong University of Science and Technology
Lead Sponsor
R
Renmin Hospital of Wuhan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign a written informed consent form.
- Male or female subjects aged 18 years and above.
- Diagnosed with Type 2 Diabetes Mellitus (T2DM).
- On initial dapagliflozin (SGLT2i) monotherapy at 10 mg daily for at least 12 weeks.
- Received metformin treatment for at least 12 weeks with stable dose (≥1500 mg/day if tolerable or maximum tolerated dose between 1000 mg/day and less than 1500 mg/day) and no dosage adjustments.
- HbA1c levels between greater than 7.0% and up to 10.0%.
- Fasting plasma glucose less than 15 mmol/L.
- Body Mass Index (BMI) of 40 kg/m2 or less.
- Estimated Glomerular Filtration Rate (eGFR) of 60 ml/min/1.73m2 or higher.
- Willing and able to maintain the same diet and exercise habits during the trial and to use a home blood glucose meter for self-monitoring and record keeping.
You will not qualify if you...
- Type 1 Diabetes Mellitus.
- Any form of secondary diabetes.
- Pending or past pancreatic or β-cell transplantation.
- History of pancreatitis or pancreatic surgery.
- Diabetic ketoacidosis or hyperosmolar coma.
- Moderate to severe liver failure (ALT, AST, or alkaline phosphatase levels over 3 times the upper normal limit).
- Acute coronary syndrome, stroke, or transient ischemic attack within last 3 months.
- Uncontrolled high blood pressure (systolic ≥160 mmHg or diastolic ≥100 mmHg).
- Hemoglobin levels less than 10 g/l or 100 mg/dl.
- More than 2 recurrent genitourinary infections in the last 3 months.
- Bariatric or gastrointestinal surgery causing chronic malabsorption within 2 years.
- Weight instability due to anti-obesity medication or other treatments in the last 3 months.
- History of cancer (except basal cell carcinoma) or cancer treatment within 5 years.
- HIV infection.
- Severe peripheral vascular disease.
- Blood disorders causing hemolysis or red blood cell instability.
- Immune system diseases or current systemic corticosteroid use.
- Thyroid hormone dose changes within 6 weeks or uncontrolled endocrine/metabolic disorders other than T2DM.
- Alcohol or drug abuse in last 3 months affecting study compliance.
- Allergy to study medications or similar drugs.
- Pregnant, breastfeeding, planning pregnancy, or unwilling to use reliable contraception during the study.
- Participation in another clinical trial within the last 30 days.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Wuhan University People's Hospital
Wuhan, Hubei, China
Actively Recruiting
2
Wuhan University People's Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
Z
ZheLong Liu, 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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