E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Young healthy men |
Unge raske mænd |
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E.1.1.1 | Medical condition in easily understood language |
Young healthy men |
Unge raske mænd |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062192 |
E.1.2 | Term | Metabolic function test normal |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053075 |
E.1.2 | Term | Microbiology test |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 |
Examine structural changes in gut microbiota before, during and after metformin treatmet. |
Undersøge strukturelle ændringer i tarmmikrobiomet før, under og efter metforminbehadling. |
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E.2.2 | Secondary objectives of the trial |
Investigate changes in metabolic markers in urine, saliva, serum and fecal samples following metformin treatment. |
Undersøge ændringen i forskellige biologiske markører målt i spyt, blodet, urinen og afføringsprøver efter metforminbehandling. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male HbA1c < 5.7 % (39 mmol/mol) at time of screening; i.e. normal glucose metabolism Caucasian (self-report of parental ethnicity) Age 18 - 35 years Weight stabile with 18.5 kg/m2 < BMI < 27.0 kg/m2 Normal kidney function as evaluated by normal p-creatinine for age
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Mand Normal blodsukker regulering (herunder HbA1c < 5.7 % (39 mmol/mol)) Kaukasier (selvrapportering af forældres etnicitetsforhold) Alder 18-35 år Vægtstabil med 18,5 kg/m2 < BMI < 27,0 kg/m2 Normal nyrefunktion
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E.4 | Principal exclusion criteria |
Oral intake of any form of prescribed medication two months prior to recruitment Chronic or acute illness Previous gastro-intestinal operation excluding appendicitis Any other significant medical reason for exclusion as determined by the investigator Unable to give informed consent Need of medical treatment during the study period
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Receptpligtig medicinsk behandling inden for de sidste 2 måneder Kronisk eller akut sygdom Anden væsentlig medicinsk årsag til udelukkelse af forsøget Manglende evne til at afgive informeret samtykke Behov for medicinsk behandling i forsøgsperioden Tidligere operationer i maveregionen fraset fjernelse af blindtarm.
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E.5 End points |
E.5.1 | Primary end point(s) |
Structural change of gut microbiota during and after metformin treatment. |
Strukturelle ændringer i tarmmikrobiomet under og efter metforminbehandling. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Changes in metabolic markers in urine, saliva, serum and fecal samples during and after metformin treatment. |
Ændringen i forskellige biologiske markører målt i spyt, blodet, urinen og afføringsprøver under og efter metforminbehandling. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Implications of metformin treatment on human gut microbiota and related physiological changes. |
Følger af metforminbehandling i det humane tarmmikrobiom og relaterede fysiologiske ændringer. |
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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 | No |
E.8.1.2 | Open | No |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Ingen behandling |
No treatment |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |