The inhibitory effect of metformin on gluconeogenesis in relation to polymorphisms in Organic Cation Transporter 1 (OCT1) in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001696-39-DK

Enrollment

Unknown

Registered

2011-06-15

Start date

2011-07-06

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Healthy volunteers (diabetes mellitus 2) MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Metformin 'Actavis' Pharmaceutical Form: Tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-4 Concentration unit: mg milligram(s) Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: inclusion criteria: Health Age 18-65 years Caucasian Included in The Pharmacogenomics Biobank of the University of Southern Denmark Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Daily medication Alcohol abuse Pregnancy Breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the inhibitory effect of metformin on gluconeogenesis in relation to polymorphisms in Organic Cation Transporter 1 (OCT1) in healthy volunteers;Secondary Objective: No;Primary end point(s): The decrease in the absolute gluconeogenesis;Timepoint(s) of evaluation of this end point: From December 2012 to July 2013	—

Secondary

Measure	Time frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -	—

Countries

Denmark

Contacts

Public ContactPlace of the trial

Institute of Public Health, Clinical Pharmacology, SDU

mmchristensen@health.sdu.dk4565503678

Outcome results

None listed

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