DiabetesPhase 4MetDipyNCT01613755
Metformin-Dipyridamole Interaction Trial
A Phase 4 study testing Metformin, dipyridamole and Metformin in people with Diabetes, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Metformin, dipyridamole and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin, dipyridamoleDrug
Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days
MetforminDrug
Metformin 500 mg twice daily for four days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Metformin, dipyridamole |
| Metformin therapy | Active comparator | Metformin 500 mg twice daily for four days Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 hours after ingestion of last dose of metformin
Peak plasma concentration (Cmax) of metformin
Peak plasma concentration (Cmax) of metformin
Measured: about 3 hours after intake of last dose of metformin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- N. Riksen, MD, PhD, Principal investigator, Radboud University Medical CenterG. Rongen, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613755
- Sponsor's protocol ID
- Met-Dipy001
- Acronym
- MetDipy
- Status last verified
- Mar 2012
- First submitted
- 25 May 2012
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dipyridamole on the Pharmacokinetics of Metformin
- ClinicalTrials.gov ID
- NCT01613755
- Acronym / sponsor ID
- MetDipy / Met-Dipy001
- Conditions
- Diabetes
- Keywords
- Effect Dipyridamole on pharmacokinetics of metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin therapy with concomitant use of dipyridamole | Active comparator | Drug: Metformin, dipyridamoleMetformin 500 mg twice daily for four days in combination with dipyridamole 200 mg twice daily for four days |
| Metformin therapy | Active comparator | Drug: MetforminMetformin 500 mg twice daily for four days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50 years
- Written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin, dipyridamoleMetformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days | Drug | Metformin therapy with concomitant use of dipyridamole |
| MetforminMetformin 500 mg twice daily for four days | Drug | Metformin therapy |
Primary outcome
The area under the curve of the metformin plasma concentration at several timepoints
Time frame: 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
Time frame: about 3 hours after intake of last dose of metformin
Peak plasma concentration (Cmax) of metformin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
N. Riksen, MD, PhD principal investigator
Radboud University Medical Center
G. Rongen, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin, dipyridamole and Metformin in people with Diabetes, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2013.