Type 2 diabetes mellitus
Conditions
Interventions
On the first study day, a non-diagnostic dose CT scan will be performed to optimally position the individual patient for the dynamic PET scan (e.g. with kidney, aorta and part of the liver inside the
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: Type 2 diabetes Age = 40 years <75 years Written informed consent
Exclusion criteria
Exclusion criteria: • Pregnant women and women of child-bearing potential who are not using reliable contraception • eGFR < 30 mL/min/1.73 m2 • Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening • Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be interrupted 1 week prior to the first study day till the end of the second study day • Subjects using a sulphonylurea. • Established peripheral arterial disease • Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) < 3 months before inclusion • History of hypersensitivity to canagliflozin or another SGLT2 inhibitor • Active malignancy • Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing • History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. • Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are dynamic PET data and images and radiation count measurement, and free plasma concentrations of canagliflozin. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are (estimated) Glomerular Filtration Rate, plasma glucose and urine glucose excretion | — |
Contacts
Public ContactHiddo Lambers Heerspink
Universitair Medisch Centrum Groningen
Outcome results
None listed