Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Bangkok Metropolitan Administration Medical College and Vajira Hospital201 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

201

Conditions

Diabetic Nephropathies

Interventions

GemigliptinDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Locations (3)

Faculty of Medicine ,Vajira Hospital

Bangkok, Thailand

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

Bangkok, Thailand

Department of Medicine,Police General Hospital,Thailand

Bangkok, Thailand

Outcomes

Primary Outcomes

Markers of renal injury

urine NGAL/Cr,urine Kim-1/Cr,urine LFABP/Cr (pg/mL)

Time frame: 6 months

Markers of vascular calcification

serum bone alkaline phosphatase(pg/mL),osteopontin (pg/mL)

Time frame: 6 months

Markers of renal injury

Protienuria (mg/day)

Time frame: 6 months

Markers of renal injury

eGFR (mL/min/1.73m2)

Time frame: 6 months

Markers of vascular calcification

Reactive oxygen species (ng/mL)

Time frame: 6 months

Markers of vascular calcification

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

Time frame: 6 months

Data from ClinicalTrials.gov

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