Status:
COMPLETED
Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification
Lead Sponsor:
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Conditions:
Diabetic Nephropathies
Eligibility:
All Genders
18-80 years
Phase:
NA
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 evalu...
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 mell...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
February 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04705506
Start Date
February 5 2017
End Date
March 1 2019
Last Update
January 14 2021
Active Locations (3)
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1
Faculty of Medicine ,Vajira Hospital
Bangkok, Thailand, 10300
2
2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand
Bangkok, Thailand, 10400
3
Department of Medicine,Police General Hospital,Thailand
Bangkok, Thailand, 10500