Research of biological mechanisms of antidiabetic drug metformin in context of human organism and microorganisms living in gut

Phase 1

• Conditions: The medical condition invertigated is Type 2 diabetes mellitus. Trial will be conducted on healthy volunteers.; MedDRA version: 19.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-001092-74-LV
• Lead Sponsor: atvian Biomedical Research and Study centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age: 18 – 64 years;
2. Caucasian race;
3. Have given written informed consent.
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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Allergies to any of Metforal 850mg components;
2. Usage of any other medicaments which are not compatible with metformin;
3. Pregnancy or lactation;
4. Current gastrointestinal, autoimmune, oncological or kidney diseases;
5. Current other health conditions which do not allow to use metformin (e.g.);
6. Usage of following medications in the past two months:
a. Antibiotics
b. Probiotics as coated tablets/capsules
c. Immunosuppressive medicaments (e.g. Methotrexate)
d. Corticosteroids (e.g. Cortisone, Hydrocortisone, Prednisolone);
e. Proton pump inhibitors (e.g. Gasec, Lomac, Gastrocaps);
7. Diarrhea in the past week;
8. Previous metformin administration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified