Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Status

Completed

Conditions

Diabetic Nephropathies

Treatments

Drug: Gemigliptin

Study type

Interventional

Funder types

Other

Identifiers

NCT04705506

186/60

Details and patient eligibility

About

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.

Full 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.

Enrollment

201 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).