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Metformin Treatment, Renal Function and Lactic Acidosis

This study has been completed.
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT01358994
First received: May 19, 2011
Last updated: May 20, 2011
Last verified: April 2011
History of Changes
  Purpose

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
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Metformin Treatment, Renal Function and Lactic Acidosis. A Population Based

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Skane University Hospital:

Enrollment: 4500
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358994

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

No publications provided

Responsible Party: Gunnar Sterner, Dept of Nephrology, Skane University Hospital
ClinicalTrials.gov Identifier: NCT01358994     History of Changes
Other Study ID Numbers: Metformin02
Study First Received: May 19, 2011
Last Updated: May 20, 2011
Health Authority: Sweden: National Board of Health and Welfare

Keywords provided by Skane University Hospital:
metformin
type 2 diabetes
e-GFR
creatinine
lactic acidosis

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

ClinicalTrials.gov processed this record on May 16, 2013