2023-504159-29-01招募中2 期
Safety and efficacy of oral semaglutide in hyperglycaemic patients after renal transplantation
Rigshospitalet, Rigshospitalet3 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年8月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- Mean sensor glucose (mmol/L) evaluated by CGM
研究概览
简要总结
The primary objective is to establish whether oral semaglutide (Rybelsus) compared with placebo, both as add-on to standard-of-care, is non-inferior in regulating plasma glucose in patients with hyperglycaemia after renal transplantation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained before any trial-related procedures are performed
- •Male or female; age: 18–80 years
- •Diagnosis of post-transplant hyperglycaemia 10 to 40 days after transplantation: Fasting plasma glucose ≥ 7.0 mmol/L or an oral glucose tolerance test with at plasma glucose ≥ 11.1 mmol/L, or Pre-transplant type 2 diabetes: Receiving glucose-lowering treatment prior to kidney transplantation.
- •An eGFR > 15 ml/min/1.73 m2 10 to 40 days after renal transplantation
- •Subject must be willing and able to comply with trial protocol
排除标准
- •Type 1 diabetes
- •High risk immunological transplantation (not including ABO-incompatible or re-transplantation)
- •Early graft rejection (all rejections verified by biopsy, except borderline rejections. Study initiations can begin 5 days after last dose of rejection treatment with methylprednisolone)
- •Chronic pancreatitis/previous acute pancreatitis
- •Known or suspected hypersensitivity to trial or related products
- •Use of DPP-4 inhibitors within five days prior to screening
- •Use of GLP-1RA within 10 days prior to screening
- •Inflammatory bowel disease
- •Previous bowel resection
- •Cardiac disease defined as decompensated heart failure (New York Heart Association class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last six months
- •Any acute condition or exacerbation of chronic condition that would in the investigator’s opinion interfere with the initial trial visit schedule and procedures.
- •Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant, or are not using adequate contraceptive methods
- •Malignancy (except basal cell carcinoma)
- •Impaired liver function (plasma ALAT > two times upper reference levels)
- •Elevated amylase (plasma amylase > two times upper reference levels)
结局指标
主要结局
Mean sensor glucose (mmol/L) evaluated by CGM
Mean sensor glucose (mmol/L) evaluated by CGM
次要结局
- Percentage time in target range (3.9–10.0 mmol/L) as evaluated by CGM
- Percentage time in tight glycaemic range (3.9–7.8 mmol/L)
- Percentage time in hyperglycaemia (level 1 (10.1–13.9 mmol/L) and level 2 (above 13.9 mmol/L) evaluated by CGM
- Glucose variability (standard deviation [mmol/L] and coefficient of variation [%]) evaluated by CGM
- Glucose management indicator (mmol/mol and %) evaluated by CGM
- HbA1c (mmol/mol and %)
- Body weight (kg)
- Body mass index (BMI) expressed as kg/m2
- Creatinine (µmol/L)
- eGFR (ml/min/1.73m2)
- Systolic blood pressure (mmHg)
- Diastolic blood pressure (mmHg)
- Pulse (beats-per-min)
- Urinary albumin-to-creatinine ratio (mg/g)
- Plasma concentrations of cholesterol, low-and high-density lipoproteins (LDL and HDL, respectively) and triglycerides
- Daily insulin dose (IE per day)
- Daily dose of immunosuppressant (prednisone, cyclosporine, tacrolimus, mycophenolate mofetile)
- Plasma concentration of semaglutide (nmol/L)
- Plasma insulin (pmol/L)
- C-peptide (nmol/L)
- Homeostatic model assessment (HOMA) for assessing beta-cell function and insulin resistance
- Blood concentrations of cyclosporine (µg/L) and tacrolimus (µg/L)
- Dose-corrected plasma semaglutide concentration (nmol/L)
- Plasma alanine transaminase (ALAT) (U/L)
- Plasma amylase (U/L)
- Gastrointestinal side effects evaluated using the Gastrointestinal symptom rating scale (GSRS) (Consist of 15 gastrointestinal symptoms that are each rated on a 7-point scale with 1 being "no discomfort" and 7 being "very severe discomfort")
- Incidence of adverse events
- Incidence of serious adverse events
- Incidence of self-reported hypoglycaemic episodes
- Incidence of out-of-target measures of blood tacrolimus and blood ciclosporin
- Incidence of 25% increase in creatinine from discharge after renal transplantation
- Incidence of admissions
- Incidence of admissions due to dehydration
- Incidence of renal graft rejection
- Incidence of renal graft failure (defined as return to dialysis)
研究者
Mads Hornum
Scientific
Rigshospitalet
研究点 (3)
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