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

Renal Insufficiency Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667300
• Other study ID #: 2016-08-144
• Status: Completed
• Phase: Phase 2
• Start date: March 16, 2017
• Est. completion date: May 14, 2019

Study information

• Verified date: September 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Type2 Diabetes Mellitus

Intervention

Drug:
• Evogliptin
This group will take daily evogliptin 5mg per oral, not linagliptin.
• Linagliptin
This group will take daily linagliptin 5mg per oral, not evogliptin

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UACR percent change at Week 24	Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)	Week 24
Secondary	UACR change at Week 24 (%)	Change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)	Week 24
Secondary	UACR change at Week 12	Change in urine albumin-to-creatinine ratio (UACR) after 12 weeks compared to baseline (mg/g	Week 12
Secondary	HbA1c change at Week 24	Change in glycated hemoglobin after 24 weeks compared to baseline	Week 24
Secondary	HbA1c change at Week 12	Change in glycated hemoglobin after 12 weeks compared to baseline	Week 12
Secondary	HbA1c less than 6.5% at Week 24	proportion of parcipitants having glycated hemoglobin less than 6.5% after 24 weeks	Week 24
Secondary	HbA1c less than 6.5% at Week 12	proportion of participants having glycated hemoglobin less than 6.5% after 12 weeks	Week 12
Secondary	HbA1c less than 7.0% at Week 24	proportion of participants having glycated hemoglobin less than 7.0% after 24weeks	Week 24
Secondary	HbA1c less than 7.0% at Week 12	proportion of participants having glycated hemoglobin less than 7.0% after 12 weeks	Week 12
Secondary	NAG (N-acetyl-ß-D-glucosaminidase) change at Week 24	Change in NAG (N-acetyl-ß-D-glucosaminidase) after 24 weeks compared to baseline (U/L)	Week 24
Secondary	NAG (N-acetyl-ß-D-glucosaminidase) change at Week 12	Change in NAG (N-acetyl-ß-D-glucosaminidase) after 12 weeks compared to baseline (U/L)	Week 12
Secondary	Cystatin-C change at Week 24	Change in urinary Cystatin-C after 24 weeks compared to baseline (mg/L)	Week 24
Secondary	Cystatin-C change at Week 12	Change in urinary Cystatin-C after 12 weeks compared to baseline (mg/L)	Week 12
Secondary	Nephrin change at Week 24	Change in Nephrin after 24 weeks compared to baseline (ug/g cr)	Week 24
Secondary	Nephrin change at Week 12	Change in Nephrin after 12 weeks compared to baseline (ug/g cr)	Week 12
Secondary	Glycated albumin change at Week 24	Change in Glycated albumin after 24 weeks compared to baseline (%)	Week 24
Secondary	Glycated albumin change at Week 12	Change in Glycated albumin after 12 weeks compared to baseline (%)	Week 12
Secondary	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)	Week 24
Secondary	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)	Week 12