The effects of SGLT2-inhibition in patients with type 2 diabetes and preserved kidney function on renal circulation, kidney function and hormones related to the circulatio

Phase 1

Active, not recruiting

• Conditions: Type 2 diabetes; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2019-004303-12-DK
• Lead Sponsor: niversity Clinic of Nephrology and Hypertension, Regional Hospital Holstebro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-23
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Over 18 years of age
•eGFR > 60 ml/min
•Type 2 diabetes diagnosed at least 1 year before inclusion and in stable Medical antidiabetic treatment for at least 3 months
•HbA1c 48 – 70 mmol/mol
•Fertile women are to use safe contraception

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Type 1 diabetes
•Alcohol or substance abuse
•Pregnancy or breastfeeding
•Anamnestic or clinical signs of heart- or liver failure
•Active cancers, aside from skin cancers (spinocellular or basocellular carcinomas)
•BMI > 35
•Allergies or unacceptable side effects to the experimental treatment or background treatment
• If investigator finds the participant unfit to complete the trial

Study & Design

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