Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

NCT04705506 — Not applicable, Completed, 201 participants, Bangkok Metropolitan Administration Medical College and Vajira Hospital

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

Registry	NCT04705506
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	201 (Actual)
Sponsor	Bangkok Metropolitan Administration Medical College and Vajira Hospital (Other gov)
Conditions	Diabetic Nephropathies
Interventions	Gemigliptin (Drug)
Dates	start 2017-02-05, primary completion 2019-03-01, completion 2019-03-01, first posted 2021-01-12, last updated 2021-01-14
Locations	3 sites in Thailand

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Gemigliptin group	Experimental	Drug: Gemigliptin	The participants will receive gemigliptin 50 mg daily
Control	Placebo comparator	Drug: Gemigliptin	The control received standard care of diabetes

Gemigliptin (Drug), also known as Treatment group: 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.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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)

Facility	City	Country
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

+Publications

Results publication: Trakarnvanich T, Satirapoj B, Suraamornkul S, Chirananthavat T, Sanpatchayapong A, Claimon T. Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition on Biomarkers of Kidney Injury and Vascular Calcification in Diabetic Kidney Disease: A Randomized Controlled Trial. J Diabetes Res. 2021 Oct 16;2021:7382620. doi: 10.1155/2021/7382620. eCollection 2021. PMID 34697593

+Investigators

Thananda Trakarnvanich, M.D., Principal investigator, Navamindradhiraj University