Changes in genes associated with metformin intolerance

Phase 1

• 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; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-003938-32-AT
• Lead Sponsor: Medizinische Universität Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-13
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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

minor age
pregnancy
Cushing's syndrome
androgen-secreting tumours

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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<br>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<br>;Primary end point(s): Metforminconcentration in Plasma<br>Metforminconcentration in Urin<br>Genotypes;Timepoint(s) of evaluation of this end point: once during routine visit

Secondary Outcome Measures

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