GlucophageSR in patients with type-2 Diabetes & CKD (eGFR 30 to 45)

• Research type

  Research Study

• Full title

  Safety, Tolerability and Effectiveness of Glocophage®SR in patients with type-2 Diabetes and Chronic Kidney Disease (eGFR 30 to 45mL/minute/1.73m2)

• IRAS ID

  87813

• Contact name

  Atir Khan

• Sponsor organisation

  Hywel Dda Health Board

• Eudract number

  2011-004245-41

• ISRCTN Number

  ISRCTN54219044

• Research summary

  The purpose of this study is to study the safety, tolerability and effectiveness of Glucophage© SR (a slow release metformin) in patients with type-2 Diabetes and chronic kidney disease (CKD) - with an eGFR 30 to 45ml/minute/1.73m2. Fear of development of lactic acidosis limits the use of metformin in certain clinical situations in patients with type-2 Diabetes. The British National formulary (BNF ?? 63) states a number of conditions (recent myocardial infarction, acute heart failure, respiratory failure, sudden deterioration in renal function), where the treatment with metformin should be discontinued or interrupted. It also states that the dose should be reviewed if estimated glomerular filteration rate (eGFR) is less than 45mL/minute/1.73m2 and to avoid if eGFR less than 30mL/minute/1.73m2. Actually, the evidence that metformin causes lactic acidosis is very weak and a number of reports and meta-analysis have argued against it. Although metformin is excreted via the kidneys, but in studies, a rise in plasma concentration of metformin alone is not proven as the likely cause of development of lactic acidosis. We believe that the guidance from National Institute of Clinical Excellence (NICE) and BNF is not based on good evidence. Due to this advice patients with type-2 Diabetes may not get the benefit of this important medicine (as it may need to be stopped). A proper study is needed to answer this scientific question. In this study we will evaluate Glucophage© SR in patients with type-2 Diabetes and Chronic kidney disease ?? CKD (eGFR 30 to 45mL/minute/1.73m2) up to a maximum daily divided dose of 1500mg.

• REC name

  Wales REC 3

• REC reference

  12/WA/0255

• Date of REC Opinion

  14 Nov 2012

• REC opinion

  Further Information Favourable Opinion