MetDipy: Metformin-Dipyridamole Interaction Trial

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01613755

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Metformin, dipyridamole Drug: Metformin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

The Effect of Dipyridamole on the Pharmacokinetics of Metformin

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Metformin, dipyridamole Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days
Active Comparator: Metformin therapy Metformin 500 mg twice daily for four days	Drug: Metformin Metformin 500 mg twice daily for four days

Arm

Intervention/Treatment

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

Drug: Metformin, dipyridamole

Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days

Active Comparator: Metformin therapy

Metformin 500 mg twice daily for four days

Drug: Metformin

Metformin 500 mg twice daily for four days

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland	Netherlands	6500 HB

Sponsors and Collaborators

Radboud University Medical Center

Investigators

Principal Investigator: N. Riksen, MD, PhD, Radboud University Medical Center
Principal Investigator: G. Rongen, MD, PhD, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radboud University Medical Center

ClinicalTrials.gov Identifier:

NCT01613755

Other Study ID Numbers:

Met-Dipy001

First Posted:

Jun 7, 2012

Last Update Posted:

Apr 29, 2013

Last Verified:

Mar 1, 2012

Keywords provided by Radboud University Medical Center

Effect Dipyridamole on pharmacokinetics of metformin

Additional relevant MeSH terms:

Metformin

Dipyridamole

Study Results

No Results Posted as of Apr 29, 2013