Type 2 Diabetes Mellitus Clinical Trial
Official title:
Metformin Treatment, Renal Function and Lactic Acidosis. A Population Based
NCT number | NCT01358994 |
Other study ID # | Metformin02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2011 |
Est. completion date | April 2011 |
Verified date | September 2018 |
Source | Skane University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 4500 |
Est. completion date | April 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Nephrology | Malmö |
Lead Sponsor | Collaborator |
---|---|
Skane University Hospital |
Sweden,
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