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. |
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Condition | Diabetes |
Intervention | Drug: Metformin, dipyridamole Drug: Metformin |
Phase | Phase 4 |
Sponsor | Radboud University |
Responsible Party | Radboud University |
ClinicalTrials.gov Identifier | NCT01613755 |
First Received | May 25, 2012 |
Last Updated | April 26, 2013 |
Last verified | March 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | May 25, 2012 |
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Last Updated Date | April 26, 2013 |
Start Date | April 2012 |
Estimated Primary Completion Date | July 2012 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Metformin-Dipyridamole Interaction Trial |
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Official Title | The 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label |
Condition | Diabetes |
Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 18 |
Estimated Completion Date | July 2012 |
Estimated Primary Completion Date | July 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01613755 |
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Other Study ID Numbers | Met-Dipy001 |
Has Data Monitoring Committee | No |
Information Provided By | Radboud University |
Study Sponsor | Radboud University |
Collaborators | Not Provided |
Investigators | Principal Investigator: N. Riksen, MD, PhD Radboud UniversityPrincipal Investigator: G. Rongen, MD, PhD Radboud University |
Verification Date | March 2012 |
Locations[ + expand ][ + ]
Radboud University Nijmegen Medical Centre | Nijmegen, Gelderland, Netherlands, 6500 HB |
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