Changes in genes associated with metformin intolerance

Genetic alterations in genes coding for transporters and metformin resistance

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003938-32-AT

Enrollment

300

Registered

2014-01-13

Start date

2014-02-12

Completion date

Unknown

Last updated

2023-10-30

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

Conditions

We want to investigate the pharmacokintetics of metformin in patients with type 2 diabetes or polycystic ovary syndrome in association with the patients genotype

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: Metformin-Hydrochlorid CAS Number: 1115-70-4 Other descriptive name: METFORMIN HYDROCHLORIDE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adults (older than 18 years) type 2 diabetics and/or diagnosed PCOS at least 1 month on metformin therapy or type 2 diabetics with change of therapy from metformin to another antidiabetic medication due to inefectiveness of metformin 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 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: minor age pregnancy Cushing's syndrome androgen-secreting tumours

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify genetic alterations (SNPs) in genes coding for transportproteins which influence the hepatic uptake or renal clearance of metformin in metformin users (type 2 diabetics and PCOS women);Secondary Objective: To determine if genetic alterations in genes coding for transportproteins influence hepatic uptake or renal clearance of metformin dependent on the BMI group Functional testing of SNPs: to determine if genetic alterations in genes coding for transport proteins influence gene expression in blood as well as the composition of gut microbiota ;Primary end point(s): Metforminconcentration in Plasma Metforminconcentration in Urin Genotypes;Timepoint(s) of evaluation of this end point: once during routine visit	—

Measure

Time frame

Main Objective: To identify genetic alterations (SNPs) in genes coding for transportproteins which influence the hepatic uptake or renal clearance of metformin in metformin users (type 2 diabetics and PCOS women);Secondary Objective: To determine if genetic alterations in genes coding for transportproteins influence hepatic uptake or renal clearance of metformin dependent on the BMI group Functional testing of SNPs: to determine if genetic alterations in genes coding for transport proteins influence gene expression in blood as well as the composition of gut microbiota ;Primary end point(s): Metforminconcentration in Plasma Metforminconcentration in Urin Genotypes;Timepoint(s) of evaluation of this end point: once during routine visit

—

Secondary

Measure	Time frame
Secondary end point(s): Metforminconcentration in Plasma and Urin according to genotype and BMI Changes in gene expression in blood according to genotype changes in gut microbiota due to genotype;Timepoint(s) of evaluation of this end point: once during routine visit	—

Countries

Austria

Contacts

Public ContactEndokrinologieambulanz

Medizinische Universität Graz, LKH Graz, Klinische Abteilung für Endokrinologie und Stoffwechsel

endo.ambulanz@klinikum-graz.at043316385 12383

Outcome results

None listed

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