Metformin-Dipyridamole Interaction Trial (MetDipy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01613755
First received: May 25, 2012
Last updated: April 26, 2013
Last verified: March 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01613755     History of Changes
Other Study ID Numbers: Met-Dipy001
Study First Received: May 25, 2012
Last Updated: April 26, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Dipyridamole
Metformin
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014