Canagliflozin REnal Distribution Intervention Trial (CREDIT); A feasibility study for the use of 18F-canagliflozin to quantify individual differences in target-site exposure in diabetes patients

Phase 2

Completed

• Conditions: Diabetes; 10012653; 10029149

• Registration Number: NL-OMON50114
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

Type 2 diabetes
Age >= 40 years <75 years
Written informed consent

Exclusion Criteria

• Subjects who participated in a trial with exposure to radiation before, are
only
allowed to participate if the total cumulative radiation burden in
their life does not
exceed 1 mSv per year, counting from the age of 18 years.
• 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
• Severe claustrophobia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are dynamic PET data and images and radiation count<br /><br>measurement, and free plasma concentrations of canagliflozin.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are (estimated) Glomerular Filtration Rate,<br /><br>plasma glucose and urine glucose excretion</p><br>