Diabetes
Conditions
Keywords
Effect Dipyridamole on 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.
Interventions
DRUGMetformin, dipyridamole
Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days
DRUGMetformin
Metformin 500 mg twice daily for four days
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The area under the curve of the metformin plasma concentration at several timepoints | 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 | about 3 hours after intake of last dose of metformin | Peak plasma concentration (Cmax) of metformin |
Countries
Netherlands
Outcome results
None listed