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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504159-29-01
Enrollment
104
Registered
2023-08-17
Start date
2024-09-03
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycaemia after renal transplantation

Brief summary

Mean sensor glucose (mmol/L) evaluated by CGM

Detailed description

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)

Interventions

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean sensor glucose (mmol/L) evaluated by CGM

Secondary

MeasureTime frame
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

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026