E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes |
Type 2-diabetes |
|
E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Type 2 sukkersyge |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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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 |
To measure the concentration of 8-oxo-Guanosine and 8-oxo-deoxyGuanosine in 24-hour urine sample before and after treatment with empagliflozin compared to placebo |
Ændring i urinudskillelsen af biomarkørerne 8-oxo-Guanosine og 8-oxo-deoxyGuanosine i døgnurin efter empagliflozin versus placebobehandling |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Not applicable |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male individuals with type 2 diabetes - Age ≥ 18 years and ≤ 75 years - HbA1c > 6.5 % - Capable of understanding oral- and written information
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- Mand med type 2 diabetes - Alder: 18-75 år - Patienten skal være i stand til at forstå mundtlig- og skriftlig informationsmateriale. - HbA1c > 6,5 %
|
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E.4 | Principal exclusion criteria |
- eGFR < 60 ml/hour/1.73 m2 - Currently in insulin treatment - Coronary artery bypass grafting, percutan coronary intervention, acute coronary syndrome, apoplexy, lung embolism, deep vein thrombosis or transitory cerebral ischemia < 6 months. - Genital infection < 14 days - p-alanin-aminotransferase ≥3 x upper limit - Psychiatric disorder - Intolerance to empagliflozin or other agents relevant to study - Non-compliance |
- eGFR < 60 ml/min - Nuværende behandling med insulin - CABG, PCI, akut koronart syndrom, apopleksi, lungeemboli, dyb vene trombose og/eller transitorisk cerebral iskæmi inden for 6 måneder - Genital svampeinfektion inden for 2 uger - p-ALAT ≥3 × øvre grænse (≥210 U/L) - Psykisk lidelse, uanset behandling eller ej - Overfølsomhed overfor empagliflozin og/eller andre indholdsstoffer. - Forsøgsdeltager vurderet non-kompliant |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcomes, urinary excretion of 8-oxo-Guanosine and 8-oxo-deoxyGuanosine in 24-hour urine samples are compared to placebo with Mann-Whitney U test. |
Urinsekretionen af 8-oxo-Guanosine og 8-oxo-deoxyGuanosine i døgnurinen sammenlingnes med placebo med Mann-Witney U test. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The trial continues until the last patient last visit - expected 31. August 2016. Analysis of the sample and data evaluation are done afterwards - expected finished 1. December 2016. |
Forsøgsperioden er indtil sidste forsøgsdeltagers sidste besøg som forventes at være 31. august 2016. Analyse af udtagne prøver, databehandling og klinisk rapport følger. Det forventes at være færdigt 1. december 2016. |
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E.5.2 | Secondary end point(s) |
Not applicable |
Not applicable |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Not applicable |
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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 | 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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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) | 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
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LVLS |
Sidste forsøgspersons sidste besøg |
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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 | |
E.8.9.1 | In the Member State concerned days | |