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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 1
- 主要终点
- UACR percent change at Week 24
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Evogliptin Group
Intervention group will take daily evogliptin 5mg per oral, not linagliptin 5mg per oral
干预措施: Evogliptin (Drug)
Linagliptin Group
Control group will take daily linagliptin 5mg per oral, not evogliptin 5mg per oral
干预措施: Linagliptin (Drug)
结局指标
主要结局
UACR percent change at Week 24
时间窗: Week 24
Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)
次要结局
- HbA1c less than 6.5% at Week 24(Week 24)
- HbA1c less than 6.5% at Week 12(Week 12)
- Nephrin change at Week 12(Week 12)
- eGFR at Week 24(Week 24)
- eGFR change at Week 12(Week 12)
- Cystatin-C change at Week 12(Week 12)
- UACR change at Week 24 (%)(Week 24)
- Glycated albumin change at Week 24(Week 24)
- Glycated albumin change at Week 12(Week 12)
- HbA1c less than 7.0% at Week 24(Week 24)
- NAG (N-acetyl-β-D-glucosaminidase) change at Week 24(Week 24)
- NAG (N-acetyl-β-D-glucosaminidase) change at Week 12(Week 12)
- UACR change at Week 12(Week 12)
- HbA1c change at Week 24(Week 24)
- HbA1c change at Week 12(Week 12)
- HbA1c less than 7.0% at Week 12(Week 12)
- Cystatin-C change at Week 24(Week 24)
- Nephrin change at Week 24(Week 24)
研究者
Jae Hyeon Kim, MD, PhD
Professor / Division of Endocrinology and metabolism
Samsung Medical Center