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New treatment option for Hyperglycemia
Official title Semaglutide Treatment for Hyperglycaemia After Renal Transplantation
ClinicalTrials.gov ID: NCT05702931
What this study is testing
What is Semaglutide 14 MG [Rybelsus]?
Semaglutide 14 MG [Rybelsus] is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hyperglycemia.
Also referred to as Rybelsus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Post-transplant hyperglycaemia occurs frequently in renal transplant recipients within the first two weeks after transplantation. Standard-of-care is primarily based on insulin treatment with the adherent risk of hypoglycaemia and weight gain.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- Type 1 diabetes
- Dialysis
- 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...
- Chronic pancreatitis/previous acute pancreatitis
- Known or suspected hypersensitivity to trial or related products
See the full eligibility criteria
- 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...
- 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
- Type 1 diabetes
- Dialysis
- 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
- Malignancy (except basal cell carcinoma)
- 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
- Impaired liver function (plasma ALAT \> two times upper reference levels)
- Elevated amylase (plasma amylase \> two times upper reference levels)
- Untreated proliferative diabetic retinopathy, untreated diabetic macular edema or active conditions of this type that are not under therapeutic control according
- Any condition that clinically significantly impairs the observation of the fundus or anterior chamber
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.