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Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency (DA1229)

Primary Purpose

Type2 Diabetes Mellitus, Albuminuria, Renal Insufficiency

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Evogliptin
Linagliptin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes Mellitus focused on measuring Type2 Diabetes Mellitus, Intervention, Albuminuria

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 20 years or older diagnosed with type 2 diabetes.
  • subjects having a level of glycated hemoglobin (HbA1c) 7.0% or more, and 10% or less.
  • subjects having urine albumin to creatinine ratio (UACR) 30 ug/mg or more, and 3000 ug/mg or less.
  • subjects having estimated glomerular filtration rate (eGFR) 30 or more.
  • subjects who had taken angiotensin II receptor blocker(ARB) or angiotensin-converting enzyme(ACE) inhibitors for more than 4 weeks.
  • subjects having body mass index (BMI) 20kg/m2 or more, 40 kg/m2 or less.
  • subjects who entirely understood all the process of clinical study protocol and voluntarily take part in the study and agree to follow rule of the study.

Exclusion Criteria:

  • subjects having type 1 diabetes, secondary diabetes, or gestational diabetes
  • subjects who had a history of surgery of resection of more than a half length of stomach or intestine.
  • subjects having more than three-fold higher levels of Aspartate Transaminase(AST) or Alanine Transaminase(ALT) than upper normal limit.
  • subjects who had taken Dipeptidyl Peptidase4(DPP4)-inhibitor or glucagon-like peptide-1(GLP-1) analogue within 8 weeks prior to screening.
  • subjects who had taken oral triple hypoglycemic agents within 8 weeks prior to screening
  • subjects taking strong cytochrome P450 3A4(CYP3A4) inhibitors or strong cytochrome P450 3A4(CYP3A4) inducers
  • subjects who are pregnants or breast feeding givers.
  • subjects who are unsuitable for clinical trial participation based on clinical laboratory test results or other reasons (e.g. taking chemotherapy or radiation for treatment for cancers).

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Evogliptin Group

Linagliptin Group

Arm Description

Intervention group will take daily evogliptin 5mg per oral, not linagliptin 5mg per oral

Control group will take daily linagliptin 5mg per oral, not evogliptin 5mg per oral

Outcomes

Primary Outcome Measures

UACR percent change at Week 24
Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)

Secondary Outcome Measures

UACR change at Week 24 (%)
Change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)
UACR change at Week 12
Change in urine albumin-to-creatinine ratio (UACR) after 12 weeks compared to baseline (mg/g
HbA1c change at Week 24
Change in glycated hemoglobin after 24 weeks compared to baseline
HbA1c change at Week 12
Change in glycated hemoglobin after 12 weeks compared to baseline
HbA1c less than 6.5% at Week 24
proportion of parcipitants having glycated hemoglobin less than 6.5% after 24 weeks
HbA1c less than 6.5% at Week 12
proportion of participants having glycated hemoglobin less than 6.5% after 12 weeks
HbA1c less than 7.0% at Week 24
proportion of participants having glycated hemoglobin less than 7.0% after 24weeks
HbA1c less than 7.0% at Week 12
proportion of participants having glycated hemoglobin less than 7.0% after 12 weeks
NAG (N-acetyl-β-D-glucosaminidase) change at Week 24
Change in NAG (N-acetyl-β-D-glucosaminidase) after 24 weeks compared to baseline (U/L)
NAG (N-acetyl-β-D-glucosaminidase) change at Week 12
Change in NAG (N-acetyl-β-D-glucosaminidase) after 12 weeks compared to baseline (U/L)
Cystatin-C change at Week 24
Change in urinary Cystatin-C after 24 weeks compared to baseline (mg/L)
Cystatin-C change at Week 12
Change in urinary Cystatin-C after 12 weeks compared to baseline (mg/L)
Nephrin change at Week 24
Change in Nephrin after 24 weeks compared to baseline (ug/g cr)
Nephrin change at Week 12
Change in Nephrin after 12 weeks compared to baseline (ug/g cr)
Glycated albumin change at Week 24
Change in Glycated albumin after 24 weeks compared to baseline (%)
Glycated albumin change at Week 12
Change in Glycated albumin after 12 weeks compared to baseline (%)
eGFR at Week 24
Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 24 weeks compared to baseline (mL/min)
eGFR change at Week 12
Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 12 weeks compared to baseline (mL/min)

Full Information

First Posted
February 20, 2018
Last Updated
September 19, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03667300
Brief Title
Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency
Acronym
DA1229
Official Title
Evogliptin Versus Linagliptin for the Effect on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency: a Multicenter, Randomised, Double-blind, Active-controlled, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study, we aimed to test the non-inferiority of evogliptin vs linagliptin in terms of reduction of albuminuria at week 24 from baseline in patients with type 2 diabetes having renal insufficiency.
Detailed Description
This is a multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study. Evogliptin (Trade name, Suganon) is a new, novel dipeptidyl peptidase-4 (DPP4) inhibitor which reveals a favorable results on glucose-lowering effect in patients with diabetes. However, its effect on renal function in patients with diabetes has been uncertained. To compare the effect of evogliptin and linagliptin on the reduction of albuminuria, we will recruit a total of 210 patients with Type 2 diabetes and renal insufficiency and allocate the participants into evogliptin group and linagliptin group with a ratio of 1:1 after radomization from 10 hospitals. After the oral administration of evogliptin 5mg per day or linagliptin 5mg per day for 24 weeks, the percent change of urine albumin-to-creatinine ratio (UACR) at Week 24 and at baseline will be measured as a primary endpoint. In addition, the percent changes of UACR, hemoglobin A1c, Cystatin-C, Nephrin, N-acetyl-beta-D-glucosaminidase (NAG), glycated albumin, estimated glomerular filtration rate (eGFR) between baseline and Week 12 or Week 24 will be studied as secondary endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus, Albuminuria, Renal Insufficiency
Keywords
Type2 Diabetes Mellitus, Intervention, Albuminuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evogliptin Group
Arm Type
Active Comparator
Arm Description
Intervention group will take daily evogliptin 5mg per oral, not linagliptin 5mg per oral
Arm Title
Linagliptin Group
Arm Type
Active Comparator
Arm Description
Control group will take daily linagliptin 5mg per oral, not evogliptin 5mg per oral
Intervention Type
Drug
Intervention Name(s)
Evogliptin
Other Intervention Name(s)
Suganon
Intervention Description
This group will take daily evogliptin 5mg per oral, not linagliptin.
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
Trajenta
Intervention Description
This group will take daily linagliptin 5mg per oral, not evogliptin
Primary Outcome Measure Information:
Title
UACR percent change at Week 24
Description
Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
UACR change at Week 24 (%)
Description
Change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)
Time Frame
Week 24
Title
UACR change at Week 12
Description
Change in urine albumin-to-creatinine ratio (UACR) after 12 weeks compared to baseline (mg/g
Time Frame
Week 12
Title
HbA1c change at Week 24
Description
Change in glycated hemoglobin after 24 weeks compared to baseline
Time Frame
Week 24
Title
HbA1c change at Week 12
Description
Change in glycated hemoglobin after 12 weeks compared to baseline
Time Frame
Week 12
Title
HbA1c less than 6.5% at Week 24
Description
proportion of parcipitants having glycated hemoglobin less than 6.5% after 24 weeks
Time Frame
Week 24
Title
HbA1c less than 6.5% at Week 12
Description
proportion of participants having glycated hemoglobin less than 6.5% after 12 weeks
Time Frame
Week 12
Title
HbA1c less than 7.0% at Week 24
Description
proportion of participants having glycated hemoglobin less than 7.0% after 24weeks
Time Frame
Week 24
Title
HbA1c less than 7.0% at Week 12
Description
proportion of participants having glycated hemoglobin less than 7.0% after 12 weeks
Time Frame
Week 12
Title
NAG (N-acetyl-β-D-glucosaminidase) change at Week 24
Description
Change in NAG (N-acetyl-β-D-glucosaminidase) after 24 weeks compared to baseline (U/L)
Time Frame
Week 24
Title
NAG (N-acetyl-β-D-glucosaminidase) change at Week 12
Description
Change in NAG (N-acetyl-β-D-glucosaminidase) after 12 weeks compared to baseline (U/L)
Time Frame
Week 12
Title
Cystatin-C change at Week 24
Description
Change in urinary Cystatin-C after 24 weeks compared to baseline (mg/L)
Time Frame
Week 24
Title
Cystatin-C change at Week 12
Description
Change in urinary Cystatin-C after 12 weeks compared to baseline (mg/L)
Time Frame
Week 12
Title
Nephrin change at Week 24
Description
Change in Nephrin after 24 weeks compared to baseline (ug/g cr)
Time Frame
Week 24
Title
Nephrin change at Week 12
Description
Change in Nephrin after 12 weeks compared to baseline (ug/g cr)
Time Frame
Week 12
Title
Glycated albumin change at Week 24
Description
Change in Glycated albumin after 24 weeks compared to baseline (%)
Time Frame
Week 24
Title
Glycated albumin change at Week 12
Description
Change in Glycated albumin after 12 weeks compared to baseline (%)
Time Frame
Week 12
Title
eGFR at Week 24
Description
Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 24 weeks compared to baseline (mL/min)
Time Frame
Week 24
Title
eGFR change at Week 12
Description
Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 12 weeks compared to baseline (mL/min)
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 20 years or older diagnosed with type 2 diabetes. subjects having a level of glycated hemoglobin (HbA1c) 7.0% or more, and 10% or less. subjects having urine albumin to creatinine ratio (UACR) 30 ug/mg or more, and 3000 ug/mg or less. subjects having estimated glomerular filtration rate (eGFR) 30 or more. subjects who had taken angiotensin II receptor blocker(ARB) or angiotensin-converting enzyme(ACE) inhibitors for more than 4 weeks. subjects having body mass index (BMI) 20kg/m2 or more, 40 kg/m2 or less. subjects who entirely understood all the process of clinical study protocol and voluntarily take part in the study and agree to follow rule of the study. Exclusion Criteria: subjects having type 1 diabetes, secondary diabetes, or gestational diabetes subjects who had a history of surgery of resection of more than a half length of stomach or intestine. subjects having more than three-fold higher levels of Aspartate Transaminase(AST) or Alanine Transaminase(ALT) than upper normal limit. subjects who had taken Dipeptidyl Peptidase4(DPP4)-inhibitor or glucagon-like peptide-1(GLP-1) analogue within 8 weeks prior to screening. subjects who had taken oral triple hypoglycemic agents within 8 weeks prior to screening subjects taking strong cytochrome P450 3A4(CYP3A4) inhibitors or strong cytochrome P450 3A4(CYP3A4) inducers subjects who are pregnants or breast feeding givers. subjects who are unsuitable for clinical trial participation based on clinical laboratory test results or other reasons (e.g. taking chemotherapy or radiation for treatment for cancers).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hyeon Kim, MD PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency

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