NCT00767351

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

Intraindividual Variation of Serum Metformin in a Cohort of Patients With Type 2 DM and Moderately Reduced Renal Function

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2009-07-01
• First posted: 2008-10-07
• Last updated: 2018-09-10