Type 2 Diabetes MellitusNCT01358994
Metformin Treatment, Renal Function and Lactic Acidosis
An observational study of Type 2 Diabetes Mellitus, run by Skane University Hospital at 1 site in Sweden.
Trial summary
From a central registry at the National Board of Health and Welfare in Sweden collect all patients in the city of Malmö prescribed metformin during two years. Glomerular filtration rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control material (n=2815) from the same town. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 4,500 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Apr 2011
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients irrespective of age prescribed metformin according to a registry for the city of Malmö
Who may be able to join
- Patients in the city of Malmö prescribed metformin at least three times during two years
- Available at least one p-creatinine during the two years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metformin Treatment, Renal Function and Lactic Acidosis. A Population Based
From a central registry at the National Board of Health and Welfare in Sweden collect all patients in the city of Malmö prescribed metformin during two years. Glomerular filtration rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU admission were also sought. The study hypothesis is that metformin is prescribed to patients with lower GFR than anticipated with very few cases of lactic acidosis registered.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- metformin, type 2 diabetes, e-GFR, creatinine, lactic acidosis
- Medical subject headings
- Diabetes Mellitus, Type 2, Acidosis, Lactic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,500 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
- NCT01358994
- Sponsor's protocol ID
- Metformin02
- Status last verified
- Sep 2018
- First submitted
- 19 May 2011
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
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
- Metformin Treatment, Renal Function and Lactic Acidosis. A Population Based
- ClinicalTrials.gov ID
- NCT01358994
- Acronym / sponsor ID
- Metformin02
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- metformin, type 2 diabetes, e-GFR, creatinine, lactic acidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,500 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 May 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.
From a central registry at the National Board of Health and Welfare in Sweden collect all patients in the city of Malmö prescribed metformin during two years. Glomerular filtration rate (eGFR) was estimated from the CKD-EPI formula (n=5408) and compared to a control material (n=2815) from the same town. All cases of severe lactic acidosis rendering ICU admission were also sought. The study hypothesis is that metformin is prescribed to patients with lower GFR than anticipated with very few cases of lactic acidosis registered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients irrespective of age prescribed metformin according to a registry for the city of Malmö
Key inclusion criteria (2 listed)
- Patients in the city of Malmö prescribed metformin at least three times during two years
- Available at least one p-creatinine during the two years
Key exclusion criteria (0 listed)
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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Skane University Hospital at 1 site in Sweden.
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 0 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.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
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?
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.