The Effect of Jardiance on Cardiac and Kidney Metabolism in Persons with Type 2 Diabetes

Phase 1

• Conditions: Diabetes, type 2; MedDRA version: 20.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000072461; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-001779-22-DK
• Lead Sponsor: Aarhus University Hospital, Department of Endocrinology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-22
• Study Completion: 2019-12-19
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

•Age: 50-70 years
•Type 2 diabetes for > 1 år
•HbA1c: 53-75 mmol/mol
•Metformin treatment as only anti diabetic medicin

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 3

Exclusion Criteria

•Diabetes for less than 1 year
•Changes in any kind of medicine through the last one month before beginning of the study.
•Recent acute myocardial infarction (< 1 year) , liver disease (ALAT > x 3 of upper normal range), kidney failure (eGFR<60 ml/min), current or previous cancer disease, anaemia (Hb < 6,5)
•Previous ketoacidosis
•Several genital infections (bacterial/fungal infections)
•Blooddonation the last 3 months before beginning of the study
•Participation in examinations with radioactive isotopes during the last 6 months before beginning of the study
•Current alcohol abuse (more than 21 units per week)

Study & Design

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