Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification
- Registration Number
- NCT04705506
- Brief Summary
Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.
- Detailed Description
This is a multi-center, prospective, randomized, placebo-controlled trial. A total of 201 participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care of diabetes mellitus for 6 months. The changes of coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), markers of vascular calcification and markers of tubular renal injury were evaluated at baseline and 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- Patients with CKD stage 1-3 (eGFR 15-60 ml/min/1.73mL)
- Non-insulin dependent diabetes mellitus , blood glucose level 30-250 mg/dL
- Had clinical features compatible with diabetic nephropathy (urine micro albuminuria > 30 g/g creatinine or has evidence of diabetic retinopathy
- History of allergy to DPP4-inhibitor
- Concurrent infectious disease
- Inflammatory diseases
- Post kidney transplantation
- Receiving cinacalcet, bisphosphonate ,previously treated with DPP4-Inhibitors and sodium-glucose cotransporter-2 inhibitor (SGLT2-i).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gemigliptin group Gemigliptin The participants will receive gemigliptin 50 mg daily Control Gemigliptin The control received standard care of diabetes
- Primary Outcome Measures
Name Time Method Markers of renal injury 6 months eGFR (mL/min/1.73m2)
Markers of vascular calcification 6 months CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Faculty of Medicine ,Vajira Hospital
🇹ðŸ‡Bangkok, Thailand
Department of Medicine,Police General Hospital,Thailand
🇹ðŸ‡Bangkok, Thailand
2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand
🇹ðŸ‡Bangkok, Thailand