Diabetes Mellitus, Type 2Phase 4POMINCT03361878
Pharmacokinetics of Metformin Intolerance
A Phase 4 study testing Metformin Hydrochloride in people with Diabetes Mellitus, Type 2 and Metformin Adverse Reaction, run by NHS Tayside.
Trial summary
Pharmacokinetic study of metformin intolerance Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metformin Adverse Reaction
- What is being tested?
- Metformin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2014to 5 May 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- White European
- Type 2 diabetes
- Meet criteria for tolerance or intolerance as described
Who cannot join
- Estimated glomerular filtration rate (eGFR) <60
- Cognitive impairment
- Pregnancy
- Concurrent treatment with: acarbose, cephalexin, cimetidine, pyrimethamine, or tyrosine kinase inhibitors
- History of gastric bypass
- Evidence of slowed gastric or intestinal motility
About this study
Pharmacokinetic study of metformin intolerance
Read the detailed description
This pharmacokinetic study recruited white European individuals with type 2 diabetes, who had previously been exposed to metformin and met the criteria for tolerance or intolerance. Intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for up to 8 weeks) but discontinued treatment with patient reported or documentation of gastrointestinal upset, leading to discontinuation (Criterion 1). Alternatively, intolerance was defined as inability to increase metformin dose above 500mg without experiencing gastrointestinal side-effects, despite having an HbA1c >53mmol/mol (Criterion 2). Tolerant individuals were defined as those taking 2000mg metformin daily in divided doses, with no side effects. Ten tolerant and ten intolerant individuals were recruited.
Participants gave written consent. They attended the research centre fasted from midnight. A baseline blood test was taken before a single dose of oral metformin was administered at 0900, with further bloods taken at 11 time points over the following 24 hours. A 24 hour urine collection was completed.
Blood samples were analysed for plasma metformin, and serum lactate concentrations.
- Being tested
- Metformin Hydrochloride
- Keywords
- Metformin, Intolerance, Pharmacokinetics
- 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.
Metformin HydrochlorideDrug
Single dose of 500mg oral metformin
| Study group | Role | What they receive |
|---|---|---|
| Metformin Tolerant | Active comparator | Not described Receives: Drug: Metformin Hydrochloride |
| Metformin Intolerant | Active comparator | Not described Receives: Drug: Metformin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin AUC
Area under the metformin concentration-time curve
Measured: 24 hours
Secondary outcomes (1)
Lactate
Change in lactate concentration (incremental AUC)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start4 May 2014
- Primary completion5 May 2016
- Study completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two arms - metformin tolerant and metformin intolerant. All participants given single dose of metformin.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Collaborators
- University of Southern Denmark, University of Dundee, Helmholtz Zentrum München
- Responsible party
- Principal investigator, Laura McCreight, NHS Tayside
- Investigators
- Laura McCreight, MBChB, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361878
- Sponsor's protocol ID
- 2013DM06
- Acronym
- POMI
- Status last verified
- Nov 2017
- First submitted
- 29 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants have been consented for data sharing. Only anonymised data would be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Metformin Intolerance
- ClinicalTrials.gov ID
- NCT03361878
- Acronym / sponsor ID
- POMI / 2013DM06
- Keywords
- Metformin, Intolerance, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Collaborators
- University of Southern Denmark, University of Dundee, Helmholtz Zentrum München
- Study start
- 4 May 2014 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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.
Pharmacokinetic study of metformin intolerance
Detailed description
This pharmacokinetic study recruited white European individuals with type 2 diabetes, who had previously been exposed to metformin and met the criteria for tolerance or intolerance. Intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for up to 8 weeks) but discontinued treatment with patient reported or documentation of gastrointestinal upset, leading to discontinuation (Criterion 1). Alternatively, intolerance was defined as inability to increase metformin dose above 500mg without experiencing gastrointestinal side-effects, despite having an HbA1c >53mmol/mol (Criterion 2). Tolerant individuals were defined as those taking 2000mg metformin daily in divided doses, with no side effects. Ten tolerant and ten intolerant individuals were recruited.
Participants gave written consent. They attended the research centre fasted from midnight. A baseline blood test was taken before a single dose of oral metformin was administered at 0900, with further bloods taken at 11 time points over the following 24 hours. A 24 hour urine collection was completed.
Blood samples were analysed for plasma metformin, and serum lactate concentrations.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms - metformin tolerant and metformin intolerant. All participants given single dose of metformin.
| Arm | Type | Receives |
|---|---|---|
| Metformin Tolerant | Active comparator | Drug: Metformin Hydrochloride |
| Metformin Intolerant | Active comparator | Drug: Metformin Hydrochloride |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- White European
- Type 2 diabetes
- Meet criteria for tolerance or intolerance as described
Key exclusion criteria (6 listed)
- Estimated glomerular filtration rate (eGFR) <60
- Cognitive impairment
- Pregnancy
- Concurrent treatment with: acarbose, cephalexin, cimetidine, pyrimethamine, or tyrosine kinase inhibitors
- History of gastric bypass
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 HydrochlorideSingle dose of 500mg oral metformin | Drug | Metformin Intolerant, Metformin Tolerant |
Primary outcome
Metformin AUC
Time frame: 24 hours
Area under the metformin concentration-time curve
1 secondary outcome
Lactate
Time frame: 24 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 5 Dec 2017.
- Individual participant dataSharing planned: Undecided. Participants have been consented for data sharing. Only anonymised data would be shared.
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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.
Laura McCreight, MBChB principal investigator
University of Dundee
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin Hydrochloride in people with Diabetes Mellitus, Type 2 and Metformin Adverse Reaction, run by NHS Tayside.
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 6 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 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Metformin AUC (time frame: 24 hours). 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 5 Dec 2017.