Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Gemigliptin on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Nephropathy: A Randomized Controlled Trial

Conditions
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Diabetic Nephropathies

Intervention / Treatment
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* Drug: Gemigliptin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center, prospective, randomized, placebo-controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemigliptin group<br>The participants will receive gemigliptin 50 mg daily | Drug: Gemigliptin<br>* We collected baseline data from all participants for demographic characteristics,comorbid conditions and biochemistry indexes.The biomarkers for vascular calcification and renal injury were collected.Baseline CAC score and CAVI were done.The patients then were randomized into 2 groups: Group 1 received gemigliptin 50 mg /day for 6 months in addition to standard treatment ,Group 2 will have standard treatment for diabetes mellitus (DM) and chronic kidney disease (CKD).The patients will be followed up every eight weeks.Fasting plasma glucose ,BUN creatinine and 24 hour urine protein were measured at each study visit.Patients were scheduled for follow-up visits at months 2,4,and 6.After 6 months ,all the blood tests,CAC score and CAVI will be done again.<br>* Other names: Treatment group;|
| Placebo Comparator: Control<br>The control received standard care of diabetes | Drug: Gemigliptin<br>* We collected baseline data from all participants for demographic characteristics,comorbid conditions and biochemistry indexes.The biomarkers for vascular calcification and renal injury were collected.Baseline CAC score and CAVI were done.The patients then were randomized into 2 groups: Group 1 received gemigliptin 50 mg /day for 6 months in addition to standard treatment ,Group 2 will have standard treatment for diabetes mellitus (DM) and chronic kidney disease (CKD).The patients will be followed up every eight weeks.Fasting plasma glucose ,BUN creatinine and 24 hour urine protein were measured at each study visit.Patients were scheduled for follow-up visits at months 2,4,and 6.After 6 months ,all the blood tests,CAC score and CAVI will be done again.<br>* Other names: Treatment group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of renal injury | urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL) | 6 months | 
| Markers of vascular calcification | serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL) | 6 months | 
| Markers of renal injury | Protienuria (mg/day) | 6 months | 
| Markers of renal injury | eGFR (mL/min/1.73m2) | 6 months | 
| Markers of vascular calcification | Reactive oxygen species (ng/mL) | 6 months | 
| Markers of vascular calcification | CAVI,CAC score(unit) ,CAVI normal less than8 ,CAC score normal less than 100 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gemigliptin, Diabetic Nephropathy, Acute Kidney Injury, Vascular Calcification