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Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Not Applicable
Completed
Conditions
Diabetic Nephropathies
Interventions
Registration Number
NCT04705506
Lead Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
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
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
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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).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Gemigliptin groupGemigliptinThe participants will receive gemigliptin 50 mg daily
ControlGemigliptinThe control received standard care of diabetes
Primary Outcome Measures
NameTimeMethod
Markers of renal injury6 months

eGFR (mL/min/1.73m2)

Markers of vascular calcification6 months

CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Faculty of Medicine ,Vajira Hospital

🇹🇭

Bangkok, Thailand

Department of Medicine,Police General Hospital,Thailand

🇹🇭

Bangkok, Thailand

2 Division of Nephrology,Department of Medicine Pramongkutklao Hospital and College of Medicine,Thailand

🇹🇭

Bangkok, Thailand

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