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Metformin-Dipyridamole Interaction Trial (MetDipy)

R

Radboud University Medical Center

Status and phase

Completed
Phase 4

Conditions

Diabetes

Treatments

Drug: Metformin
Drug: Metformin, dipyridamole

Study type

Interventional

Funder types

Other

Identifiers

NCT01613755
Met-Dipy001

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 50 years old

Volunteers

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

Trial design

18 participants in 2 patient groups

Metformin therapy with concomitant use of dipyridamole
Active Comparator group
Description:
Metformin 500 mg twice daily for four days in combination with dipyridamole 200 mg twice daily for four days
Treatment:
Drug: Metformin, dipyridamole
Metformin therapy
Active Comparator group
Description:
Metformin 500 mg twice daily for four days
Treatment:
Drug: Metformin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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