Metformin Treatment, Renal Function and Lactic Acidosis

NCT ID: NCT01358994

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Skane University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gunnar Sterner

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept of Nephrology

Malmo, , Sweden

Countries

Sweden

Other Identifiers

Metformin02

Identifier Type: -

Identifier Source: org_study_id