The effect of dipyridamole on the pharmacokinetics of metformin.

The effect of dipyridamole on the pharmacokinetics of metformin. - Met-Dipy interaction trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000363-24-NL

Enrollment

Registered

2012-02-22

Start date

2012-04-18

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

The antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole are often used concomitantly in patients with diabetes who have suffered a transient ischemic attack or stroke. Gastrointestinal absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has been reported to inhibit hENT4 transport in vitro. Dipyridamole may therefore negatively influence the uptake of metformin from the gastrointestinal tract. MedDRA version

Interventions

Trade Name: Metformin Product Name: Metformin Product Code: 100904 Pharmaceutical Form: Tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-4 Current Sponsor code: metformin Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 18-50 years - 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 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Smoking - Hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg) - Diabetes Mellitus (fasting glucose >7 mmol/L or random glucose >11 mmol/L) - History of any cardiovascular disease - Renal dysfunction (MDRD <60 ml/min) - ECG abnormalities, other than first grade AV-block or right bundle branch block

Design outcomes

Primary

Measure	Time frame
Main Objective: To study whether dipyridamole reduces gastrointestinal absorption of metformin.;Secondary Objective: Not applicable.;Primary end point(s): The area under the curve of the metformin plasma concentration of metformin at t=0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, and 10 hours after the intake of the last tablet of metformin and the Cmax.;Timepoint(s) of evaluation of this end point: t=0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, and 10 hours after the intake of the last tablet of metformin	—

Measure

Time frame

Main Objective: To study whether dipyridamole reduces gastrointestinal absorption of metformin.;Secondary Objective: Not applicable.;Primary end point(s): The area under the curve of the metformin plasma concentration of metformin at t=0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, and 10 hours after the intake of the last tablet of metformin and the Cmax.;Timepoint(s) of evaluation of this end point: t=0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, and 10 hours after the intake of the last tablet of metformin

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Netherlands

Contacts

Public ContactDept. of Pharmacology-Toxicology

Radboud University Medical Centre

N.Riksen@aig.umcn.nl+31243613691

Outcome results

None listed

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