Metformin-Dipyridamole Interaction Trial

NCT ID: NCT01613755

Last Updated: 2013-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Metformin therapy with concomitant use of dipyridamole

Metformin 500 mg twice daily for four days in combination with dipyridamole 200 mg twice daily for four days

Group Type ACTIVE_COMPARATOR

Metformin, dipyridamole

Intervention Type DRUG

Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days

Metformin therapy

Metformin 500 mg twice daily for four days

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 500 mg twice daily for four days

Interventions

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Metformin, dipyridamole

Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days

Intervention Type DRUG

Metformin

Metformin 500 mg twice daily for four days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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N. Riksen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

G. Rongen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Met-Dipy001

Identifier Type: -

Identifier Source: org_study_id

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