The Effect of Sodium-Glucose Cotransporter 2 Inhibitors on Advanced Glycation End Products
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in AGE levels
研究概览
简要总结
Single-center open-label multiple dose randomized two period cross-over study to examine Advanced Glycation End Product (AGE) levels in human subjects pre and post empagliflozin administration.
详细描述
Single-center open-label multiple dose randomized two period cross-over study.
The North-Shore Long Island Jewish Institutional Review Board will be used to approve our study protocol.
All patients will give written informed consent and comply with the Helsinki agreement and good clinical practices guidelines.
Treatment Plan:
Eligible patients will be randomized to receive linagliptin 5mg daily or empagliflozin 25mg daily for 30 days followed by a 30 day washout period and crossover. All pre-existing diabetic medications will continue unchanged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •glomerular filtration rate ≥ 30 ml/min/1.73 m2 body-surface area
- •A1C ≥ 7% any higher limit
- •SLGT-2 inhibitor naïve
- •On stable doses of current medications for at least 3 months.
排除标准
- •Indication of liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 2 x upper limit of normal during screening or run-in phase
- •Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
- •Contraindications to background therapy according to the local label
- •Any uncontrolled endocrine disorder except type 2 diabetes
- •Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who were nursing, pregnant, or of child-bearing potential and were not practicing an acceptable method of birth control, or did not plan to continue using this method throughout the study, or did not agree to submit to periodic pregnancy testing during the trial
- •o Acceptable methods of birth control include tubal ligation, transdermal patch, intrauterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence, double barrier method, vasectomy of partner
- •Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
- •Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug and/or follow-up
研究组 & 干预措施
Linagliptin
Eligible patients were randomized to receive linagliptin 5mg daily for 30 days.
干预措施: empagliflozin (Drug)
Empagliflozin
Eligible patients were randomized empagliflozin 25mg daily for 30 days.
干预措施: linagliptin (Drug)
结局指标
主要结局
Change in AGE levels
时间窗: 30 days
Measurement of serum and urinary AGE levels
次要结局
- Change in blood pressure(30 days)
- Change in weight(30 days)