E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronary microvascular function in patients with type 2 diabetes |
Hjertets mikrovaskulære funktion hos patienter med type 2 sukkersyge |
|
E.1.1.1 | Medical condition in easily understood language |
Function of the small vessels of the heart in patients with type 2 diabetes |
Funktionen af hjertets små blodkar hos patienter med type 2 sukkersyge |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10072685 |
E.1.2 | Term | Microvascular coronary artery disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate the effect of treatment with SGLT2 inhibitors on the coronary microvasculature in patients with type 2 diabetes mellitus |
at undersøge effekten af behandling med SGLT2 hæmmer på hjertets mikrovaskulære funktion |
|
E.2.2 | Secondary objectives of the trial |
not applicable |
not applicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
• Type 2 sukkersyge, defineret som værende i medicinsk behandling for type 2 sukkersyge i mindst 12 uger forud for randomisering • 40-80 år • eGFR≥45 l per minut per 1.73 m2 overfladeareal |
|
E.4 | Principal 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.
|
• Allergi overfor Empagliflozin ellers dets komponenter • Hba1c<58 mmol/mol • Tidligere myokardieinfarkt der involverer LAD forsyningsområdet • Tidligere koronar by-pass operation (CABG) • Reversibel myokardie iskæmi bestemt ved adenosin stres ekkokardiografi • tegn på moderat til svær leversygdom • Præ-menopausale kvinder (sidste menstruation ≤1 forud for afgivelse af informeret samtykke) som ammer, er gravide eller fertile og som ikke anvender en acceptabel form for prævention gennem hele studiet. • Gaviditet (graviditets test udføres ved inklusionen) • Alkohol misbrug indenfor 3 måneder forud for afgivelse af informeret samtykke eller anden tilstand der kan føre til nedsat compliance i studiet. • Indtag af en anden forsøgsmedicin i et andet studie indenfor 30 dage forud for indtag af studiemedicinen i det aktuelle studie, eller deltagelse i et andet studie med forsøgsmedicin.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Changes in coronary flow velocity reserve (CFVR) assessed by transthoracic doppler stress echocardiography (TTDSE) |
• Ændring i den koronare blodgennemstrømningshastigheds reserve (CFVR) målt ved transtorakal doppler stres ekkokardiografi (TTDSE) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before and after each treatment period of 12 weeks (2 treatment periods) |
Før og efter hver behandlingsperiode på 12 uger (2 behandlingsperioder) |
|
E.5.2 | Secondary end point(s) |
• Changes in cardiac function assessed by speckle tracking echocardiography • Changes in biovhemical markers of cardiac metabolism
|
• Ændring i hjertets funktion bestemt ved speckle tracking ekkokardiografi • Ændring i biokemiske markører for hjertets metabolisme
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before and after each treatment period of 12 weeks (2 treatment periods) |
Før og efter hver behandlingsperiode på 12 uger (2 behandlingsperioder) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To explain the mechanisms behing the cardiovascular benefits seen in previous trials. We hypothesize that SGLT2 inhibition improves cardiac function through effects on coronary microvascular function. Knowledge of the mechanisms behind the effects of SGLT2- inhibition could result in an adjustment in guidelines for diabetic care leading to the use of SGLT2 inhibitors as first-line treatment choice in specific subpopulations of patients with diabetes type 2. |
De gavnlige kardiovaskulære effekter ved SGLT2 hæmmer behandling set i tidligere studier ønskes forklaret. Hypotesen er, at SGLT2 hæmmer behandling forbedrer hjertets funktion via effekter på hjertets mikrovaskulære funktion. Kendskab til mekanismerne bag de kardiovaskulære effekter kunne føre til en ændring i guidelines således, at SGLT2 hæmmer behandling blev anbefalet som førstevalg til specifikke subgrupper af patienter med sukkersyge. |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Sidste besøg for den sidste studiedeltager |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |