Safety and efficacy of oral semaglutide in hyperglycaemic patients after renal transplantation

Rigshospitalet0 个研究点目标入组 104 人开始时间: 2023年7月25日最近更新: 2024年7月22日

适应症

试验速览

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•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 15 days after transplantation: Fasting plasma glucose = 7.0 mmol/L or an oral glucose tolerance test with at plasma glucose = 11.1 mmol/L, An eGFR > 15 ml/min/1.73 m2 10 to 15 days after renal transplantation, Subject must be willing and able to comply with trial protocol

•Type 1 diabetes, 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), Type 2 diabetes pre-transplant (except HbA1c = 52mmol/mol and lifestyle-treated. HbA1c should be measured within three months pre-transplant), Dialysis, High risk immunological transplantation (not including ABO-incompatible or re-transplantation), Early graft rejection, 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

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