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Metformin-Dipyridamole Interaction Trial (MetDipy)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01613755
First Posted: June 7, 2012
Last Update Posted: April 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University
  Purpose
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.

Condition Intervention Phase
Diabetes Drug: Metformin, dipyridamole Drug: Metformin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: The Effect of Dipyridamole on the Pharmacokinetics of Metformin

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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.

  • Peak plasma concentration (Cmax) of metformin [ Time Frame: about 3 hours after intake of last dose of metformin ]
    Peak plasma concentration (Cmax) of metformin


Enrollment: 18
Study Start Date: April 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: Metformin, dipyridamole
Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days
Active Comparator: Metformin therapy
Metformin 500 mg twice daily for four days
Drug: Metformin
Metformin 500 mg twice daily for four days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613755


Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: N. Riksen, MD, PhD Radboud University
Principal Investigator: G. Rongen, MD, PhD Radboud University
  More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01613755     History of Changes
Other Study ID Numbers: Met-Dipy001
First Submitted: May 25, 2012
First Posted: June 7, 2012
Last Update Posted: April 29, 2013
Last Verified: March 2012

Keywords provided by Radboud University:
Effect Dipyridamole on pharmacokinetics of metformin

Additional relevant MeSH terms:
Metformin
Dipyridamole
Hypoglycemic Agents
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents


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