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Completed

NCT Number: NCT01613755

Metformin-Dipyridamole Interaction Trial

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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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. The area under the curve of the metformin plasma concentration at several timepoints

    Time frame: 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.

  2. Peak plasma concentration (Cmax) of metformin

    Time frame: about 3 hours after intake of last dose of metformin

    Peak plasma concentration (Cmax) of metformin

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The Effect of Dipyridamole on the Pharmacokinetics of Metformin

Acronym: MetDipy

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 7, 2012
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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