Clinical Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors in Urinary Albumin to Creatinine Ratio in Patients With Overt Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Change in Microalbuminuria Level
研究概览
简要总结
The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.
This study is being performed to test the effectiveness of sitagliptin as compared to a placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it will reduce protein levels in their urine. Protein levels in the urine are a marker of the severity of kidney disease.
详细描述
The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an ACE inhibitor or ARB. However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Albumin/creatinine ratio between 30-299 mg/dl.
- •type 2 diabetes mellitus (T2DM) with hemoglobin A1c between 7 and 9%.
- •Stable BP control of less than 145/90 on treatment with ACE or ARB for more than three months prior and during the trial.
- •Glomerular filtration rate (GFR) of 60 mL/min/1.73m2 or more.
- •Age between 18-75 years old.
- •For women: at least two years postmenopausal, surgically sterile, or using an acceptable contraceptive regiment to include oral contraceptive pill (OCP), intrauterine device (IUD), double barrier, depo-provera, or subcutaneous progestin implant and negative urine pregnancy test at trial start.
排除标准
- •Pregnancy.
- •GFR less than 60 mL/min/73m
- •Have a history of malignancy other than basal cell or squamous cell skin cancer and have not yet been treated, are currently being treated, or were diagnosed less than 5 years prior to Visit
- •Advanced liver disease.
- •Subjects cannot be on DPP-4 inhibitor or glycolipoprotein (GLP-1) agonist for at least 4 months before the study start.
- •Psychiatric condition that would prevent subject from following directions. Per PI discretion.
研究组 & 干预措施
Sitagliptin
100 mg/day for 3 months
干预措施: Sitagliptin (Drug)
Placebo
1 pill/day for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Microalbuminuria Level
时间窗: Six months
Decrease in microalbuminuria level
次要结局
未报告次要终点