CClinicalTrials.gg
CompletedNCT01358994Updated Sep 10, 2018

Metformin Treatment, Renal Function and Lactic Acidosis

An observational study in Type 2 Diabetes Mellitus, sponsored by Skane University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Skane University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,500
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • metformin
  • type 2 diabetes
  • e-GFR
  • creatinine
  • lactic acidosis
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 4,500 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Skane University Hospital is the lead sponsor of 71 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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

Exclusion Criteria:

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,500 participants (actual)
06

Study locations

1 site
  • Dept of Nephrology
    Malmö, SE 20502, Sweden
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01358994
Lead sponsor
Skane University Hospital
Responsible party
Gunnar Sterner (PhD, Skane University Hospital) — Principal investigator
First posted
May 24, 2011
Start date
Jan 2011
Primary completion
Jan 2011
Completion
Apr 2011
Last update
Sep 10, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion