Safety and efficacy of oral semaglutide in hyperglycaemic patients after renal transplantatio
- Conditions
- Hyperglycaemia after renal transplantationTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-504159-29-01
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 104
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Secondary objectives aim to evaluate the effect of oral semaglutide on renal graft function, weight, use of insulin, cardiovascular parameters and safety parameters (plasma semaglutide concentration, gastrointestinal side effects, dose of immunosuppressants).;Primary end point(s): Mean sensor glucose (mmol/L) evaluated by CGM
- Secondary Outcome Measures
Name Time Method