Clinical trial NCT03667300: Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type2 Diabetes Mellitus
Albuminuria
Renal Insufficiency
Keywords: Type2 Diabetes Mellitus
Intervention
Albuminuria
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 209
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: UACR percent change at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: UACR change at Week 24 (%)
timeFrame: Week 24
measure: UACR change at Week 12
timeFrame: Week 12
measure: HbA1c change at Week 24
timeFrame: Week 24
measure: HbA1c change at Week 12
timeFrame: Week 12
measure: HbA1c less than 6.5% at Week 24
timeFrame: Week 24
measure: HbA1c less than 6.5% at Week 12
timeFrame: Week 12
measure: HbA1c less than 7.0% at Week 24
timeFrame: Week 24
measure: HbA1c less than 7.0% at Week 12
timeFrame: Week 12
measure: NAG (N-acetyl-β-D-glucosaminidase) change at Week 24
timeFrame: Week 24
measure: NAG (N-acetyl-β-D-glucosaminidase) change at Week 12
timeFrame: Week 12
measure: Cystatin-C change at Week 24
timeFrame: Week 24
measure: Cystatin-C change at Week 12
timeFrame: Week 12
measure: Nephrin change at Week 24
timeFrame: Week 24
measure: Nephrin change at Week 12
timeFrame: Week 12
measure: Glycated albumin change at Week 24
timeFrame: Week 24
measure: Glycated albumin change at Week 12
timeFrame: Week 12
measure: eGFR at Week 24
timeFrame: Week 24
measure: eGFR change at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae Hyeon Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: