Variation in Serum Levels of Metformin in Patients With Reduced Renal Function

NCT ID: NCT00767351

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-07-31

Brief Summary

Metformin is widely used for treatment of type 2 diabetes mellitus. Side-effects are few and mainly from the gastrointestinal tract. Since metformin is cleared from the blood exclusively via the kidneys reduced renal function is a relative contraindication. We have earlier demonstrated that metformin safely can be used to a lower GFR level of 30 ml/min/1.73. Below that level the risk of lactacidosis, a severe complication, increases.

In the present study we plan to analyse serum levels of metformin repeatedly in patients with moderate renal failure (CKD = GFR of 30-60 ml/min/1.73). Blood samples will be taken as trough values in the morning, week 0, 2, 4, and 8 and at four weeks a blood sample will be taken two hours after intake of the morning dose of metformin. Renal function will be estimated with creatinine and cystatin C at each occasion. The intraindividual variation of metformin will be calculated.

The study rests on a new method for measuring metformin. The technique uses Liquid Chromatography Tandem Mass Spectometry (LCMSMS). Proteins are removed from serum by adding acetonitrile to the sample. After centrifugation a diluted portion of the supernatant is injected into the LCMSMS-system. The total runtime for a sample is 6 minutes.

The study will show if variation in serum levels of metformin measured in the same patient is high or low and thus give us better understanding whether a change i serum level is due to biological variation or to increased retention caused by progressive renal failure.

Conditions

Diabetes Mellitus Type 2; Metformin; Pharmacokinetics

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients above the age of 18 years with type 2 diabetes mellitus.
• Reduced renal function measured as estimated GFR (below 60 ml/min/1.73).
• Treatment with metformin on going.

Exclusion Criteria

• Severely reduced GFR (< 30 ml(min/1.73)

• Minimum Eligible Age: 18 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

References

Frid A, Sterner GN, Londahl M, Wiklander C, Cato A, Vinge E, Andersson A. Novel assay of metformin levels in patients with type 2 diabetes and varying levels of renal function: clinical recommendations. Diabetes Care. 2010 Jun;33(6):1291-3. doi: 10.2337/dc09-1284. Epub 2010 Mar 9.

Reference Type: DERIVED

PMID: 20215446 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id