Metformin-Dipyridamole Interaction Trial

NCT01613755 | Completed Phase 4

• 1 other identifier: Met-Dipy001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Effect Dipyridamole on pharmacokinetics of metformin

Outcome Measures

Primary Outcomes (2)

• 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

• Peak plasma concentration (Cmax) of metformin

  Peak plasma concentration (Cmax) of metformin

  about 3 hours after intake of last dose of metformin

Study Arms (2)

Metformin therapy with concomitant use of dipyridamole

ACTIVE COMPARATOR

Metformin 500 mg twice daily for four days in combination with dipyridamole 200 mg twice daily for four days

Drug: Metformin, dipyridamole

Metformin therapy

ACTIVE COMPARATOR

Metformin 500 mg twice daily for four days

Drug: Metformin

Interventions

Metformin, dipyridamole DRUG

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

Metformin therapy with concomitant use of dipyridamole

Metformin DRUG

Metformin 500 mg twice daily for four days

Metformin therapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Metformin; Dipyridamole

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• N. Riksen, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• G. Rongen, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: June 7, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 29, 2013

Record last verified: 2012-03

Locations

NL (1)