Metformin-Dipyridamole Interaction Trial

NCT01613755 — Phase 4, Completed, 18 participants, Radboud University Medical Center

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The Effect of Dipyridamole on the Pharmacokinetics of Metformin

Registry	NCT01613755, acronym MetDipy
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: none
Enrollment	18 (Actual)
Sponsor	Radboud University Medical Center (Other)
Conditions	Diabetes
Interventions	Metformin, dipyridamole, Metformin (Drug)
Dates	start 2012-04-01, primary completion 2012-07-01, completion 2012-07-01, first posted 2012-06-07, last updated 2013-04-29
Locations	1 site in Netherlands

-Summary

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. It has recently been suggested that the gastrointestinal absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hENT4). Dipyridamole has been reported to inhibit hENT4 transport in vitro. The aim of this research proposal is to study the pharmacokinetic interaction between metformin and dipyridamole. The investigators hypothesize that dipyridamole reduces the gastrointestinal absorption of metformin. If this hypothesis can be confirmed, then the results of this study can explain in part the high variability in plasma metformin concentrations in patients treated with diabetes, and can be used to optimize pharmacotherapy in patients with diabetes.

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+Arms and interventions

Arm	Type	Interventions	Description
Metformin therapy with concomitant use of dipyridamole	Active comparator	Drug: Metformin, dipyridamole	Metformin 500 mg twice daily for four days in combination with dipyridamole 200 mg twice daily for four days
Metformin therapy	Active comparator	Drug: Metformin	Metformin 500 mg twice daily for four days

Metformin, dipyridamole (Drug): Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days
Metformin (Drug): Metformin 500 mg twice daily for four days

+Outcome measures

Primary outcomes

The area under the curve of the metformin plasma concentration at several timepoints [10 hours after ingestion of last dose of metformin]: The area under the curve of the metformin plasma concentration at t=0, t=1, t=2, t=2.5, t=3, t=3.5, t=4, t=5, t=6, t=8, and t=10 hours after the intake and the Cmax.
Peak plasma concentration (Cmax) of metformin [about 3 hours after intake of last dose of metformin]: Peak plasma concentration (Cmax) of metformin

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* Age 18-50 years
* Written informed consent

Exclusion Criteria:

* Smoking
* Hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
* Diabetes Mellitus (fasting glucose >7.0 mmol/L or random glucose >11 mmol/L)
* History of any cardiovascular disease
* Concomitant use of medication
* Renal dysfunction (MDRD <60 ml/min)
* ECG abnormalities, other than firs grade AV-block or right bundle branch block

+Locations (1)

Facility	City	Country	Status
Radboud University Nijmegen Medical Centre	Nijmegen, Gelderland	Netherlands

+Investigators

N. Riksen, MD, PhD, Principal investigator, Radboud University Medical Center
G. Rongen, MD, PhD, Principal investigator, Radboud University Medical Center