Efficacy and Safety of Empagliflozin in Renal Transplant Recipients With Post-transplantation Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Weighted mean glucose
研究概览
简要总结
This is a single-center, prospective, controlled, double-blind, randomized study. A total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (PTDM) will be included more than 1 year after transplantation and randomized 1:1 to empagliflozin (Jardiance®) 10 mg or placebo once daily for 24 weeks. Patients with estimated glomerular filtration rate below 30 mL/min will be excluded. Oral glucose tolerance test, 72h continuous glucose monitoring (iPro™2), measurement of arterial stiffness, body composition (including visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at baseline and after 24 weeks in addition to standard safety measurements. Two safety visits will be performed at week 8 and 16. All concomitant medication, diet and exercise will be kept stable during the study period. The objective of the present study is to answer whether empagliflozin safely and effectively improves glucose metabolism together with weight loss in renal transplant recipients with PTDM.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant recipient transplanted more than 1 year ago
- •Stable renal function (<20% deviation in serum creatinine within last 2 months)
- •Stable immunosuppressive therapy ≥3 months before inclusion
- •Diagnosed with PTDM:
- •(fasting plasma glucose ≥7.0 mmol/l and/or 2-hour plasma glucose ≥11.1 mmol/l following an oral glucose tolerance test)
- •Signed informed consent and expected cooperation of the patients
排除标准
- •Estimated GFR <30 ml/min/1.73 m2
- •Pregnant or nursing mothers
- •Hypersensitivity to the active substance (IMP) or to any of the excipients
- •Any reason why, in the opinion of the investigator, the patient should not participate
研究组 & 干预措施
Placebo
1 capsule once daily for 24 weeks
干预措施: Placebo (Other)
Empagliflozin
10 mg once daily for 24 weeks
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Weighted mean glucose
时间窗: 24 weeks
The primary endpoint will be change from baseline in weighted mean glucose at week 24 compared to placebo. Each patient will perform continuous plasma glucose monitoring (CGM, iProTM2) for 72 hours at baseline and after 24 weeks.
次要结局
- Body weight(24 weeks)
- Bone mineral density(24 weeks)
- Glycated hemoglobin (HbA1c)(24 weeks)
- Waist-hip-ratio(24 weeks)
- Body composition(24 weeks)
- Blood pressure(24 weeks)
- Fasting plasma glucose(24 weeks)
- 2 hour glucose concentration(24 weeks)
- Arterial stiffness(24 weeks)
- Renal function(24 weeks)
研究者
Trond Jenssen
Professor
Oslo University Hospital