Coronary microvascular function in patients with type 2 diabetes MedDRA version: 19.1 Level: PT Classification code 10072685 Term: Microvascular coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Jardiance
Product Name: Empagliflozin
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Other descriptive name: EMPAGLIFLOZIN
Concentration unit
Sponsors
Bispebjerg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in cardiac function assessed by speckle tracking echocardiography • Changes in biovhemical markers of cardiac metabolism ;Timepoint(s) of evaluation of this end point: Before and after each treatment period of 12 weeks (2 treatment periods) | — |
Countries
Denmark
Contacts
Public ContactEva Prescott
Bispebjerg University Hospital
Outcome results
None listed