E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Microvessel angina is a result of myocardial ischemia from insufficient myocardial perfusion secondary to microvessel dysfunction. Diseased arteries may appear angiographically normal but are dysfunctioning and blood flow is not sufficient increased. In the absence of stenosis of major coronary arteries, coronary flow reserve (CFR) reflects coronary microcirculation. CFR is reduced in patients diabetes and is a strong predictor of poor prognosis.
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E.1.1.1 | Medical condition in easily understood language |
Microvessel angina is a result of myocardial ischemia from insufficient myocardial perfusion secondary to microvessel dysfunction. Diseased arteries may appear angiographically |
Mikrovaskulær angina skyldes utilstrækkelig blodgennemblødning i hjertet pga. sygdom i de små hjertekar. Arterierne ser normale ud på angiografi men de små hjertekar reagerer ikke normalt. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065566 |
E.1.2 | Term | Microvascular angina |
E.1.2 | System Organ Class | 100000004849 |
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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 |
The aim of this study is to explore the short term effects of GLP-1 treatment on coronary microcirculations estimated by coronary flow reserve (CFR) in patients with type 2 diabetes as a pilot study for a long term study |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age: 40-75 years
Type 2 diabetes with clinical indication of liraglutide treatment (not acceptable glycemic regulation on oral antidiabetic medication)
BMI>25 kg/m2
HbA1c</=9 %
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E.4 | Principal exclusion criteria |
Insulin treatment
HbA1c>9 %.
Documented significant stenosis of the left anterior descending artery (LAD) at coronary angiography or CT-angiography.
Pregnancy, physical or mental disability, active cancer, severe co-morbidity with limited life-expectancy, significant renal or hepatic co-morbidity, chronic alcohol abuse or heart failure with a left ventricular ejection fraction </= 45%, atrial fibrillation, chronic or previous acute pancreatitis, inflammatory bowel disease
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E.5 End points |
E.5.1 | Primary end point(s) |
Coronary flow reserve (CFR).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline, after 5 weeks and after 10 weeks of treatment |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline, after 5 weeks and after 10 weeks of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
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 | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
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
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The last visit of the last subject undergoing endpoint measurements |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |