Type 2 DiabetesPhase 1NCT01726764
Interaction Between St John's Wort and Metformin?
A Phase 1 study testing St John's Wort and Metformin in people with Type 2 Diabetes and Depression, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The goal of the study is to examine the difference of the pharmacokinetics of metformin with and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose tolerance test, changes in OCT1 mRNA in plasma… Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Depression
- What is being tested?
- St John's Wort and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to May 2014
- Phase
- Phase 1
- 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 18-64 years
- Homozygous for common genetic variants in the genes organic cation transporter 1/2 (OCT1/OCT2)
- Normal values of biomarkers accounting for: Liver and kidney function, and normal blood glucose
Who cannot join
- Chronic alcohol abuse
- Hypersensitivity to metformin or St John's Wort
- Daily intake of drugs requiring prescription
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark
Odense, DK-5000
About this study
Official title: Is There a Pharmacokinetic Interaction Between St John's Wort and Metformin?
The goal of the study is to examine the difference of the pharmacokinetics of metformin with and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile following this possible interaction.
- Conditions
- Type 2 Diabetes, Depression
- Being tested
- St John's Wort, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St John's WortOther
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | 7 days of pretreatment with metformin before full pharmacokinetics and other goals are investigated.
Minimum 1 week of washout after this period. 3 weeks of pretreatment with St John's Wort and the last 7 days metformin is ingested again, and the same effect parameters as described above is performed again Receives: Other: St John's Wort; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Area Under Curve (AUC) 0-24h of metformin
Change in 0-24h AUC of metformin after 3 weeks of treatment with St John's Wort
Measured: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion
Secondary outcomes (3)
Oral glucose tolerance test (OGTT)
Changes in: Plasma-glucose, serum-insulin, glucagon-like peptide 1 (GLP-1) and connecting-peptides (C-peptides) during the oral glucose tolerance test, measured at 0, 0.5, 1, 1.5 and 2 hours after metformin ingestion.
Measured: During the first 2 hours of each metformin ingestion
Pharmacokinetics of metformin
Determination of other pharmacokinetic parameters of metformin such as clearance (CL), absorption fraction (F), distribution volume (V), the minimum concentration at steady state (Css,min), elimination half life (T 1/2) etc.
Measured: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion, which will be used to determine the pharmacokinetic parameters mentioned below
Change in messenger RiboNucleic Acid (mRNA)
Changes in mRNA encoding OCT1 will be measured at 4 different time points to give an insight to the importance of St John's Wort effect on the OCT1 production
Measured: Will be measured 4 times: At inclusion (t=0 on that day), at t=0 in both periods and minimum 3 weeks after finalization of the study (t=0 on that day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tore B. Stage, University of Southern Denmark
- Investigators
- Per Damkier, MD ph.d., Principal investigator, University of Southern DenmarkTore B. Stage, M.Sc. Pharm, Principal investigator, University of Southern DenmarkKim Brøsen, Professor, MD, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726764
- Sponsor's protocol ID
- AKF-382
- Status last verified
- Dec 2014
- First submitted
- 2 Nov 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Pharmacokinetic Interaction Between St John's Wort and Metformin?
- ClinicalTrials.gov ID
- NCT01726764
- Acronym / sponsor ID
- AKF-382
- Conditions
- Type 2 Diabetes, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Nov 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 goal of the study is to examine the difference of the pharmacokinetics of metformin with and without a 3 weeks pretreatment of St John's Wort. Furthermore secondary objectives include changes in GLP-1, C-peptide, serum-insulin and plasma-glucose during an oral glucose tolerance test, changes in OCT1 mRNA in plasma and changes in leptin and lipid-profile following this possible interaction.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Other: St John's Wort, Drug: Metformin7 days of pretreatment with metformin before full pharmacokinetics and other goals are investigated. Minimum 1 week of washout after this period. 3 weeks of pretreatment with St John's Wort and the last 7 days metformin is ingested again, and the same effect parameters as described above is performed again |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men aged 18-64 years
- Homozygous for common genetic variants in the genes organic cation transporter 1/2 (OCT1/OCT2)
- Normal values of biomarkers accounting for: Liver and kidney function, and normal blood glucose
Key exclusion criteria (3 listed)
- Chronic alcohol abuse
- Hypersensitivity to metformin or St John's Wort
- Daily intake of drugs requiring prescription
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 |
|---|---|---|
| St John's Wort | Other | Metformin |
| Metformin | Drug | Metformin |
Primary outcome
Change in Area Under Curve (AUC) 0-24h of metformin
Time frame: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion
Change in 0-24h AUC of metformin after 3 weeks of treatment with St John's Wort
3 secondary outcomes
Oral glucose tolerance test (OGTT)
Time frame: During the first 2 hours of each metformin ingestion
Pharmacokinetics of metformin
Time frame: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion, which will be used to determine the pharmacokinetic parameters mentioned below
Change in messenger RiboNucleic Acid (mRNA)
Time frame: Will be measured 4 times: At inclusion (t=0 on that day), at t=0 in both periods and minimum 3 weeks after finalization of the study (t=0 on that day)
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 3 Dec 2014.
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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.
Per Damkier, MD ph.d. principal investigator
University of Southern Denmark
Tore B. Stage, M.Sc. Pharm principal investigator
University of Southern Denmark
Kim Brøsen, Professor, MD study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing St John's Wort and Metformin in people with Type 2 Diabetes and Depression, run by University of Southern Denmark at 1 site in Denmark.
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 3 inclusion and 3 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 3 Dec 2014. 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 Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in Area Under Curve (AUC) 0-24h of metformin (time frame: Concentration of metformin at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 hours after metformin ingestion). 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 3 Dec 2014.