Metformin-Dipyridamole Interaction Trial

Diabetes Clinical Trial

— MetDipy  

Official title:

The Effect of Dipyridamole on the Pharmacokinetics of Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613755
• Other study ID #: Met-Dipy001
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2012
• Last updated: April 26, 2013
• Start date: April 2012
• Est. completion date: July 2012

Study information

• Verified date: March 2012
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Metformin, dipyridamole
Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days
• Metformin
Metformin 500 mg twice daily for four days

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area under the curve of the metformin plasma concentration at several timepoints	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.	10 hours after ingestion of last dose of metformin	No
Primary	Peak plasma concentration (Cmax) of metformin	Peak plasma concentration (Cmax) of metformin	about 3 hours after intake of last dose of metformin	No