Effect of SGLT2 inhibition on the function of small vessels of the heart in type 2 diabetes.

Phase 1

• Conditions: Coronary microvascular function in patients with type 2 diabetes; MedDRA version: 19.1Level: PTClassification code 10072685Term: Microvascular coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-000240-17-DK
• Lead Sponsor: Bispebjerg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-07
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

•Type 2 diabetes mellitus defined as medical treatment with antidiabetic drugs for 12 weeks prior to randomization
•40-80 years of age
•eGFR=45 l per minute per 1.73 m2 of body surface area

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 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

•Allergy to Empagliflozin or its components
•Hba1c<58 mmol/mol
•Previous myocardial infarction involving the LAD supply area
•Previous coronary artery by-pass graft (CABG) operation
•Reversible myocardial ischemia assessed by adenosine stress echocardiography
•Indication of moderate-severe liver disease
•Pre-menopausal women (last menstruation =1 year prior to informed consent) who are nursing, pregnant, or of child-bearing potential and are not practicing an acceptable method of birth control throughout the study.
•Pregnancy (pregnancy test will be done at inclusion)
•Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake
•Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial involving an investigational drug.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the effect of treatment with SGLT2 inhibitors on the coronary microvasculature in patients with type 2 diabetes mellitus;Secondary Objective: not applicable;Primary end point(s): •Changes in coronary flow velocity reserve (CFVR) assessed by transthoracic doppler stress echocardiography (TTDSE);Timepoint(s) of evaluation of this end point: Before and after each treatment period of 12 weeks (2 treatment periods)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Changes in cardiac function assessed by speckle tracking echocardiography<br>•Changes in biovhemical markers of cardiac metabolism<br>;Timepoint(s) of evaluation of this end point: Before and after each treatment period of 12 weeks (2 treatment periods)