An interventional study of Gemigliptin in Diabetic Nephropathies, sponsored by Bangkok Metropolitan Administration Medical College and Vajira Hospital. Completed at 3 sites in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-14.
Sponsored by Bangkok Metropolitan Administration Medical College and Vajira Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
The participants will receive gemigliptin 50 mg daily
Drug: Gemigliptin
The control received standard care of diabetes
Drug: Gemigliptin
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.
Also known as: Treatment group
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
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Bangkok Metropolitan Administration Medical College and Vajira Hospital