Actively Recruiting
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
Led by Huazhong University of Science and Technology · Updated on 2025-06-13
170
Participants Needed
2
Research Sites
8 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
Researchers are evaluating the change in glycated hemoglobin (HbA1c) levels over 24 weeks in patients with type 2 diabetes mellitus (T2DM) who have poor glucose control despite treatment with metformin and SGLT2 inhibitors (dapagliflozin). This study compares the effects of adding cofrogliptin every two weeks versus daily linagliptin to the existing combination therapy. The study is a phase 4, randomized, open-label trial led by Huazhong University of Science and Technology. Participants will be randomly assigned to one of two groups: one receiving triple therapy with cofrogliptin added to metformin and SGLT2i, and the other receiving linagliptin added to metformin and SGLT2i. Both groups include patients who have been on stable doses of metformin and SGLT2i for at least 12 weeks but still have inadequate blood glucose control. Treatments will be administered according to these regimens for 24 weeks. During the study, participants will undergo assessments including HbA1c levels, 2-hour postprandial glucose (2h-PPG), fasting plasma glucose (FPG), and weight measurements from enrollment through the 24-week treatment period. Participants will be asked to maintain consistent diet and exercise routines and use a home blood glucose meter to monitor and record their glucose levels. The main outcome measured is the change in HbA1c from baseline to 24 weeks, with additional safety and efficacy evaluations throughout the study period.
CONDITIONS
Brief 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.
- 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 at least 12 weeks with a stable dose during screening (≥1500 mg/day if tolerable or maximum tolerated dose between 1000 and 1500 mg/day) with no dosage adjustment.
- HbA1c levels between 7.0% and 10.0%.
- Fasting plasma glucose (FPG) less than 15 mmol/L.
- Body Mass Index (BMI) 40 kg/m2 or less.
- Estimated Glomerular Filtration Rate (eGFR) 60 ml/min/1.73m2 or higher.
- Agree to maintain the same diet and exercise habits during the trial and able to use a home blood glucose meter for self-monitoring and recording.
You will not qualify if you...
- Type 1 Diabetes Mellitus.
- Any type of secondary diabetes.
- Pending or having undergone pancreatic or β-cell transplantation.
- History of pancreatitis or pancreatic resection.
- Diabetic ketoacidosis or hyperosmolar coma.
- Moderate or severe liver failure (ALT, AST, or alkaline phosphatase levels more than 3 times the upper limit of normal).
- Acute coronary syndrome, stroke, or transient ischemic attack within the last 3 months.
- Uncontrolled high blood pressure (systolic ≥160 mmHg or diastolic ≥100 mmHg).
- Hemoglobin levels less than 10 g/dl.
- More than 2 recurrent genitourinary infections in the last 3 months.
- History of bariatric or gastrointestinal surgery causing chronic malabsorption within 2 years.
- Weight instability due to anti-obesity treatments or other interventions within 3 months.
- Cancer history or treatment within the last 5 years (except basal cell carcinoma).
- HIV infection.
- Severe peripheral vascular disease.
- Blood cancers or disorders causing red blood cell instability.
- Immune system diseases or ongoing systemic corticosteroid treatment.
- Recent changes in thyroid hormone dosage or uncontrolled endocrine/metabolic disorders besides T2DM.
- Alcohol or drug abuse within 3 months or any condition likely to reduce study compliance.
- Allergy to study drugs or similar compounds.
- Pregnant or breastfeeding women or those not using reliable contraception during the study period.
- Participation in another clinical trial within 30 days prior to enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive triple combination therapy with either cofrogliptin or linagliptin added to metformin and SGLT2i to manage type 2 diabetes.
Regular visits during the 24 weeks of treatment
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
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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