NCT04705506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2.1 years

First QC Date

January 9, 2021

Last Update Submit

January 12, 2021

Conditions

Diabetic Nephropathies

Keywords

GemigliptinDiabetic NephropathyAcute Kidney InjuryVascular Calcification

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Gemigliptin group

EXPERIMENTAL

The participants will receive gemigliptin 50 mg daily

Drug: Gemigliptin

Control

PLACEBO COMPARATOR

The control received standard care of diabetes

Drug: Gemigliptin

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.

Also known as: Treatment group
ControlGemigliptin group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Faculty of Medicine ,Vajira Hospital

Bangkok, 10300, Thailand

Location

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

Bangkok, 10400, Thailand

Location

Department of Medicine,Police General Hospital,Thailand

Bangkok, 10500, Thailand

Location

Related Publications (1)

  • 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: 34697593DERIVED

MeSH Terms

Conditions

Diabetic NephropathiesAcute Kidney InjuryVascular Calcification

Interventions

LC15-0444

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesRenal InsufficiencyCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thananda Trakarnvanich, M.D.

    Navamindradhiraj University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multi-center, prospective, randomized, placebo-controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2021

First Posted

January 12, 2021

Study Start

February 5, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

January 14, 2021

Record last verified: 2021-01

Locations

TH(3)