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Metformin Treatment, Renal Function and Lactic Acidosis

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ClinicalTrials.gov Identifier: NCT01358994
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : May 24, 2011
Information provided by:
Skane University Hospital

Brief 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. 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.

Condition or disease
Type 2 Diabetes Mellitus

Study Type : Observational
Actual Enrollment : 4500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Metformin Treatment, Renal Function and Lactic Acidosis. A Population Based
Study Start Date : January 2011
Primary Completion Date : January 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients irrespective of age prescribed metformin according to a registry for the city of Malmö

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358994

Dept of Nephrology
Malmö, Sweden, SE 20502
Sponsors and Collaborators
Skane University Hospital

Responsible Party: Gunnar Sterner, Dept of Nephrology, Skane University Hospital
ClinicalTrials.gov Identifier: NCT01358994     History of Changes
Other Study ID Numbers: Metformin02
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: April 2011

Keywords provided by Skane University Hospital:
type 2 diabetes
lactic acidosis

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Acidosis, Lactic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acid-Base Imbalance
Hypoglycemic Agents
Physiological Effects of Drugs