Metformin-Dipyridamole Interaction Trial

Overview[ - collapse ][ - ]

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.
ConditionDiabetes
InterventionDrug: Metformin, dipyridamole
Drug: Metformin
PhasePhase 4
SponsorRadboud University
Responsible PartyRadboud University
ClinicalTrials.gov IdentifierNCT01613755
First ReceivedMay 25, 2012
Last UpdatedApril 26, 2013
Last verifiedMarch 2012

Tracking Information[ + expand ][ + ]

First Received DateMay 25, 2012
Last Updated DateApril 26, 2013
Start DateApril 2012
Estimated Primary Completion DateJuly 2012
Current 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
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin-Dipyridamole Interaction Trial
Official TitleThe Effect of Dipyridamole on the Pharmacokinetics of Metformin
Brief Summary
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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
ConditionDiabetes
InterventionDrug: Metformin, dipyridamole
Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days
Drug: Metformin
Metformin 500 mg twice daily for four days
Study Arm (s)
  • 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
  • Active Comparator: Metformin therapy
    Metformin 500 mg twice daily for four days

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment18
Estimated Completion DateJuly 2012
Estimated Primary Completion DateJuly 2012
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNetherlands

Administrative Information[ + expand ][ + ]

NCT Number NCT01613755
Other Study ID NumbersMet-Dipy001
Has Data Monitoring CommitteeNo
Information Provided ByRadboud University
Study SponsorRadboud University
CollaboratorsNot Provided
Investigators Principal Investigator: N. Riksen, MD, PhD Radboud UniversityPrincipal Investigator: G. Rongen, MD, PhD Radboud University
Verification DateMarch 2012

Locations[ + expand ][ + ]

Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB