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Metformin Treatment, Renal Function and Lactic Acidosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358994
First Posted: May 24, 2011
Last Update Posted: May 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Skane University Hospital
  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:


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

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
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
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


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

Responsible Party: Gunnar Sterner, Dept of Nephrology, Skane University Hospital
ClinicalTrials.gov Identifier: NCT01358994     History of Changes
Other Study ID Numbers: Metformin02
First Submitted: May 19, 2011
First Posted: May 24, 2011
Last Update Posted: May 24, 2011
Last Verified: April 2011

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

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