Diabetes Mellitus Type 2NCT00767351
Variation in Serum Levels of Metformin in Patients With Reduced Renal Function
An observational study of Diabetes Mellitus Type 2 and Metformin, run by Skane University Hospital.
Trial summary
Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Metformin, Pharmacokinetics
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jul 2009
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 DM followed at the out-patient department at the hospital will be asked to join the study
Who may be able to join
- Patients above the age of 18 years with type 2 diabetes mellitus.
- Reduced renal function measured as estimated GFR (below 60 ml/min/1.73).
- Treatment with metformin on going.
Who cannot join
- Severely reduced GFR (< 30 ml(min/1.73)
About this study
Official title: Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function
Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases.
In the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated.
Read more
The study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.
The study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.
- Conditions
- Diabetes Mellitus Type 2, Metformin, Pharmacokinetics
- Medical subject headings
- Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunnar Sterner, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767351
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2018
- First submitted
- 6 Oct 2008
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Frid A, Sterner GN, Londahl M, Wiklander C, Cato A, Vinge E, Andersson A. Novel assay of metformin levels in patients with type 2 diabetes and varying levels of renal function: clinical recommendations. Diabetes Care. 2010 Jun;33(6):1291-3. doi: 10.2337/dc09-1284. Epub 2010 Mar 9.
PubMed 20215446
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function
- ClinicalTrials.gov ID
- NCT00767351
- Acronym / sponsor ID
- 001
- Conditions
- Diabetes Mellitus Type 2, Metformin, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Oct 2008 (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.
Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases.
In the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated.
The study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.
The study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 DM followed at the out-patient department at the hospital will be asked to join the study
Key inclusion criteria (3 listed)
- Patients above the age of 18 years with type 2 diabetes mellitus.
- Reduced renal function measured as estimated GFR (below 60 ml/min/1.73).
- Treatment with metformin on going.
Key exclusion criteria (1 listed)
- Severely reduced GFR (< 30 ml(min/1.73)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Sep 2018.
- Derived from this study: PubMed 20215446Frid A, Sterner GN, Londahl M, Wiklander C, Cato A, Vinge E, Andersson A. Novel assay of metformin levels in patients with type 2 diabetes and varying levels of renal function: clinical recommendations. Diabetes Care. 2010 Jun;33(6):1291-3. doi: 10.2337/dc09-1284. Epub 2010 Mar 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 and Metformin, run by Skane University Hospital.
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 1 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 10 Sep 2018. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00767351, which also lists 1 linked publication.
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 10 Sep 2018.