Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

NCT ID: NCT04705506

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-05
• Study Completion Date: 2019-03-01

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.

Conditions

Diabetic Nephropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemigliptin group

The participants will receive gemigliptin 50 mg daily

Group Type: EXPERIMENTAL

Gemigliptin

Intervention Type: DRUG

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.

Control

The control received standard care of diabetes

Group Type: PLACEBO_COMPARATOR

Gemigliptin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Treatment group

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangkok Metropolitan Administration Medical College and Vajira Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Thananda Trakarnvanich

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thananda Trakarnvanich, M.D.

Role: PRINCIPAL_INVESTIGATOR

Navamindradhiraj University

Locations

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

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 34697593 (View on PubMed)

Other Identifiers

186/60

Identifier Type: -

Identifier Source: org_study_id