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

Pharmacodynamics of antidiabetic drug metformin - MIKROMET

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001092-74-LV

Enrollment

Unknown

Registered

2017-03-27

Start date

2017-03-23

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The medical condition invertigated is Type 2 diabetes mellitus. Trial will be conducted on healthy volunteers. MedDRA version: 19.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Metforal 850 Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the pharmacodynamic effects of 7 days long administration of metformin on healthy subjects.;Secondary Objective: 1) Determination of microbiome profile in association with tolerability of metformin; 2) Distinguishing dietary effects on microbiome from those of metformin treatment; 3) To evaluate the changes of clinical biochemistry parameters.;Primary end point(s): End of experimental week - 7th day of metformin administration;Timepoint(s) of evaluation of this end point: 8th day, 12 - 14h after the last dose of metformin	—

Measure

Time frame

Main Objective: To assess the pharmacodynamic effects of 7 days long administration of metformin on healthy subjects.;Secondary Objective: 1) Determination of microbiome profile in association with tolerability of metformin; 2) Distinguishing dietary effects on microbiome from those of metformin treatment; 3) To evaluate the changes of clinical biochemistry parameters.;Primary end point(s): End of experimental week - 7th day of metformin administration;Timepoint(s) of evaluation of this end point: 8th day, 12 - 14h after the last dose of metformin

—

Secondary

Measure	Time frame
Secondary end point(s): Safety endpoint: in case of adverse effects, health problems or other reasons;Timepoint(s) of evaluation of this end point: Every day of experimental week	—

Countries

Latvia

Contacts

Public ContactBiobank Unit

Genome Centre

gec@biomed.lu.lv+37167473083

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026