A study in diabetes patients to assess the feasability of using radioactive labeled canagliflozin in investigating difference in drug exposure in target organs between responding and non-responding patients by using PET imaging.

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-001835-29-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-16
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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
• Severe claustrophobia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified