Metformin-Dipyridamole Interaction Trial (MetDipy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01613755
First received: May 25, 2012
Last updated: April 26, 2013
Last verified: March 2012

May 25, 2012
April 26, 2013
April 2012
July 2012   (final data collection date for primary outcome measure)
  • The area under the curve of the metformin plasma concentration at several timepoints [ Time Frame: 10 hours after ingestion of last dose of metformin ] [ Designated as safety issue: No ]
    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 [ Time Frame: about 3 hours after intake of last dose of metformin ] [ Designated as safety issue: No ]
    Peak plasma concentration (Cmax) of metformin
Same as current
Complete list of historical versions of study NCT01613755 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Metformin-Dipyridamole Interaction Trial
The Effect of Dipyridamole on the Pharmacokinetics of Metformin

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Diabetes
  • 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
  • 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
    Intervention: Drug: Metformin, dipyridamole
  • Active Comparator: Metformin therapy
    Metformin 500 mg twice daily for four days
    Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01613755
Met-Dipy001
No
Radboud University
Radboud University
Not Provided
Principal Investigator: N. Riksen, MD, PhD Radboud University
Principal Investigator: G. Rongen, MD, PhD Radboud University
Radboud University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP