In short
There are currently 3 ongoing clinical trials investigating treatments for hyperglycaemia, a condition characterised by elevated blood glucose levels. These trials are focused on managing high blood sugar in specific patient groups, including those who have received kidney transplants and critically ill patients in intensive care. The studies are testing different approaches to blood sugar control, including oral medications and insulin therapy protocols.
Clinical trial locations
- Belgium
- Denmark
Study on the Safety and Effectiveness of Oral Semaglutide for Patients with High Blood Sugar After Kidney Transplantation
This clinical trial is investigating the use of oral semaglutide, marketed as Rybelsus, for managing elevated blood sugar levels in patients who have recently undergone kidney transplantation. The study compares the medication with a placebo to assess its safety and effectiveness in this specific patient group.
Main inclusion criteria: To participate in this trial, you must be between 18 and 80 years of age and have been diagnosed with high blood sugar 10 to 15 days after receiving a kidney transplant. Specifically, your fasting plasma glucose should be at least 7.0 mmol/L, or your plasma glucose should be at least 11.1 mmol/L after a glucose tolerance test. Your kidney function, measured by eGFR, should be greater than 15 ml/min/1.73 m². You must also be willing to provide written informed consent and follow the trial procedures.
Main exclusion criteria: You cannot participate if you have not received a kidney transplant or do not have elevated blood sugar levels following transplantation. The trial excludes patients under 18 or over 75 years of age, those who are pregnant or breastfeeding, and individuals with a history of severe allergic reactions to the study medication. Participation in another clinical trial or having any medical condition that might make it unsafe to participate also disqualifies you from this study.
Trial focus and goals: The primary goal is to determine whether oral semaglutide can effectively manage blood sugar levels in kidney transplant patients compared to placebo. The study will monitor various health indicators including body weight, blood pressure, and kidney function over a 14-day period. Participants will have their blood glucose levels continuously monitored using a continuous glucose monitor to assess how well the medication works. The trial will also track any side effects or adverse events that may occur during treatment.
Investigational drug: Oral semaglutide, branded as Rybelsus, is a GLP-1 receptor agonist taken by mouth that helps the body produce more insulin to lower blood sugar levels. In this trial, the dosage starts at 3 mg and may be increased to 7 mg and then to 14 mg, depending on individual response and tolerance.
Study on the Safety and Effectiveness of Oral Semaglutide for Patients with High Blood Sugar After Kidney Transplantation
This trial examines the safety and effectiveness of oral semaglutide in managing elevated blood sugar levels that occur after kidney transplantation. The study compares the medication to a placebo while patients continue to receive their standard care.
Main inclusion criteria: You must be between 18 and 80 years old and have a diagnosis of post-transplant high blood sugar 10 to 15 days after your kidney transplant. This is defined as having a fasting plasma glucose level of 7.0 mmol/L or higher, or a plasma glucose level of 11.1 mmol/L or higher after a glucose tolerance test. Your kidney function must show an eGFR greater than 15 ml/min/1.73 m². You need to provide written informed consent and be willing and able to follow the trial protocol.
Main exclusion criteria: Patients who have not had a kidney transplant or do not have high blood sugar after transplantation cannot participate. The study excludes those outside the specified age range and individuals who are part of vulnerable populations requiring special protection. Patients who cannot take oral medications or are unable to follow study procedures are also excluded.
Trial focus and goals: The study aims to assess whether oral semaglutide can effectively maintain blood sugar levels within a target range compared to placebo. Researchers will evaluate various health indicators including body weight, blood pressure, and kidney function. The trial uses continuous glucose monitoring to track blood sugar levels over time and will monitor for any side effects or adverse events. The findings could help improve treatment options for kidney transplant patients experiencing elevated blood sugar levels.
Investigational drug: Oral semaglutide, known commercially as Rybelsus, works by mimicking a natural hormone in the body that helps regulate insulin and blood sugar. The medication is taken once daily in tablet form with dosages of 3 mg, 7 mg, or 14 mg as determined by the study protocol.
Study of Insulin Treatment for Blood Glucose Control in Adult Critically Ill Patients with Stress Hyperglycemia
This study focuses on managing stress-induced high blood sugar in critically ill patients being treated in intensive care units. The trial investigates whether strict blood sugar control using insulin leads to better outcomes compared to allowing higher blood sugar levels.
Main inclusion criteria: You must be at least 18 years old and currently admitted to one of the participating intensive care units. Both males and females can participate. You must have elevated blood sugar levels while being critically ill, a condition known as stress hyperglycemia. You must be willing to have your blood sugar levels monitored and managed according to the study protocol, and you must not be receiving parenteral nutrition during your first week in the ICU.
Main exclusion criteria: The trial excludes patients under 18 or over 80 years of age, pregnant women, and nursing mothers. Patients with pre-existing diabetes or those receiving parenteral nutrition before ICU admission cannot participate. Other exclusion criteria include known allergies to insulin, severe liver disease, kidney failure requiring dialysis, terminal illness with life expectancy less than 7 days, and burns covering more than 20% of body surface. Patients who cannot provide informed consent or are participating in other clinical trials are also excluded.
Trial focus and goals: The purpose is to determine if maintaining tight blood sugar control within normal fasting ranges using a specific dosing protocol, called the Leuven algorithm, leads to better recovery outcomes in critically ill adult patients. The study monitors how the treatment affects patients' recovery during their ICU stay, tracking how long patients need intensive care support, checking for complications, and following overall progress. The trial includes follow-up assessments at 90 days, 2 years, and potentially up to 5 years to evaluate long-term recovery and organ function.
Investigational drugs: The trial uses human insulin administered through an intravenous line to maintain strict blood glucose control. The insulin dose is adjusted according to blood sugar measurements using the Leuven algorithm, with a maximum daily dose of up to 1,200 international units. The study also examines the effect of withholding parenteral nutrition during the first week in intensive care as part of the treatment approach.
Summary
These three clinical trials represent focused efforts to improve blood sugar management in specific patient populations experiencing elevated glucose levels. Two trials are concentrated in Denmark and focus on the same medication, oral semaglutide, for patients who develop high blood sugar after kidney transplantation. These studies target a specific complication that can arise from the immunosuppressive medications necessary to prevent organ rejection.
The third trial, located in Belgium, takes a different approach by investigating insulin therapy protocols in critically ill patients experiencing stress-induced high blood sugar in intensive care settings. This reflects the distinct needs of patients whose elevated blood sugar is triggered by severe illness rather than transplantation or pre-existing diabetes.
All three trials share a common goal of determining optimal strategies for blood sugar control while carefully monitoring patient safety and outcomes. The trials in Denmark focus on the convenience and effectiveness of oral medication, while the Belgian study examines the benefits of strict intravenous insulin protocols. Together, these studies address different clinical scenarios where managing elevated blood sugar levels is crucial for patient recovery and long-term health outcomes.
