Pharmacogenetics of MetforminPhase 4NCT01400191
The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1
A Phase 4 study testing Metformin in people with Pharmacogenetics of Metformin, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacogenetics of Metformin
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Written consent
- Genotyped in OCT1 for (M420del and R61C)
Who cannot join
- Daily medication
- Alcohol abuse
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinical pharmacology, Institute og public health, University of Southern Denmark
Odense, 5000
About this study
Official title: The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers
The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters.
- Conditions
- Pharmacogenetics of Metformin
- Being tested
- Metformin
- Keywords
- Metformin, Hypoglycemic Agents, Diabetes Mellitus, Type 2, Gluconeogenesis, Pharmacodynamics, Pharmacogenetics
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Homozygote wildtype OCT1 | Active comparator | Not described Receives: Drug: Metformin |
| Heterozygote OCT1 | Active comparator | Not described Receives: Drug: Metformin |
| Homozygote OCT1 variant | Active comparator | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous glucose production
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pharmacogenetics of MetforminStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Principal investigator, Mette Marie Hougaard Christensen, University of Southern Denmark
- Investigators
- Mette Marie H Christensen, MD, Principal investigator, Department of Public Health, Clinical Pharmacology, University of Southen Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400191
- Sponsor's protocol ID
- AKF 379
- Status last verified
- Jun 2015
- First submitted
- 21 Jul 2011
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kolnes KJ, Moller PM, Kruse R, Christensen MMH, Kjobsted R, Hey-Mogensen M, Andersen B, Handberg A, Hojlund K. Metformin increases glycolysis and the stress-induced cytokine GDF15 but not FGF21 in humans. Front Endocrinol (Lausanne). 2026 Mar 18;17:1797525. doi: 10.3389/fendo.2026.1797525. eCollection 2026.
PubMed 41928890Christensen MM, Hojlund K, Hother-Nielsen O, Stage TB, Damkier P, Beck-Nielsen H, Brosen K. Endogenous glucose production increases in response to metformin treatment in the glycogen-depleted state in humans: a randomised trial. Diabetologia. 2015 Nov;58(11):2494-502. doi: 10.1007/s00125-015-3733-2. Epub 2015 Aug 14.
PubMed 26271344
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1 (OCT1) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01400191
- Acronym / sponsor ID
- AKF 379
- Conditions
- Pharmacogenetics of Metformin
- Keywords
- Metformin, Hypoglycemic Agents, Diabetes Mellitus, Type 2, Gluconeogenesis, Pharmacodynamics, Pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jul 2011 (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 aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy volunteers with functional OCT1-transporters.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Homozygote wildtype OCT1 | Active comparator | Drug: Metformin |
| Heterozygote OCT1 | Active comparator | Drug: Metformin |
| Homozygote OCT1 variant | Active comparator | Drug: Metformin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers
- Written consent
- Genotyped in OCT1 for (M420del and R61C)
Key exclusion criteria (4 listed)
- Daily medication
- Alcohol abuse
- Pregnancy
- Breastfeeding
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 |
|---|---|---|
| MetforminThe study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers. | Drug | Heterozygote OCT1, Homozygote OCT1 variant, Homozygote wildtype OCT1 |
Primary outcome
Endogenous glucose production
Time frame: 48 hours
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 26 Jun 2015.
- Derived from this study: PubMed 41928890Kolnes KJ, Moller PM, Kruse R, Christensen MMH, Kjobsted R, Hey-Mogensen M, Andersen B, Handberg A, Hojlund K. Metformin increases glycolysis and the stress-induced cytokine GDF15 but not FGF21 in humans. Front Endocrinol (Lausanne). 2026 Mar 18;17:1797525. doi: 10.3389/fendo.2026.1797525. eCollection 2026.
- Derived from this study: PubMed 26271344Christensen MM, Hojlund K, Hother-Nielsen O, Stage TB, Damkier P, Beck-Nielsen H, Brosen K. Endogenous glucose production increases in response to metformin treatment in the glycogen-depleted state in humans: a randomised trial. Diabetologia. 2015 Nov;58(11):2494-502. doi: 10.1007/s00125-015-3733-2. Epub 2015 Aug 14.
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.
Mette Marie H Christensen, MD principal investigator
Department of Public Health, Clinical Pharmacology, University of Southen Denmark
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 in people with Pharmacogenetics of Metformin, 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 4 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 26 Jun 2015. 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 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?
Endogenous glucose production (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400191, which also lists 2 linked publications.
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 26 Jun 2015.