Metformin-Dipyridamole Interaction Trial

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: Metformin, dipyridamole; Drug: Metformin

• Registration Number: NCT01613755
• Lead Sponsor: Radboud University Medical Center

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 available

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-04
• Study First Submitted: 2012-05-25
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2013-04-26
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age 18-50 years
• Written informed consent

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Metformin therapy with concomitant use of dipyridamole	Metformin, dipyridamole	Metformin 500 mg twice daily for four days in combination with dipyridamole 200 mg twice daily for four days
Metformin therapy	Metformin	Metformin 500 mg twice daily for four days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands