Saxagliptin Add-on vs Increased Metformin in T2Diabetic Patients

• Research type

  Research Study

• Full title

  A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients with Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

• IRAS ID

  28015

• Contact name

  Ian Farmer

• Sponsor organisation

  AstraZeneca

• Eudract number

  2009-012775-10

• ISRCTN Number

  n/a

• Research summary

  Type 2 diabetes (T2D) is characterised by loss of sensitivity to insulin or failure of the beta calls in the pancreas to produce insulin, consequently sugar levels rise (hyperglycaemia) and end organ damage can occur (kidney, eyes, heart and skin) as a result of changes to the blood vessels. Many patients with T2D do not reach adequate blood glucose control when taking median doses of metformin (a well established treatment for T2D). The addition of another glucose-lowering medicine with a different mechanism of action might show benefits, compared to increasing the dose of metformin. Saxagliptin (study drug) is a medication that increases the levels of GLP-1 (gut hormone). This hormone affects glucose metabolism in a number of ways leading to a reduction in blood glucose level. This study is being carried out to see if saxagliptin added to submaximal doses of metformin is more efficacious and better tolerated than increasing the metformin close to the maximally recommended doses. All patients who enter the study will be taking metformin and will continue to take it. Patients will be randomly allocated to an add-on treatment of saxagliptin or the ??uptitration? (increased dose) of metformin on top of their usual metformin dose. The study will be conducted in 8 countries across Europe in both GP and hospital sites. Patients will be in the study for 24 weeks and will be required to attend 11 visits. During these visits the patient??s blood glucose level will be measured to assess their response to treatment and for routine safety blood tests. In addition, safety assessments will be done to check adverse events and record other medications the patient is using.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/90

• Date of REC Opinion

  5 Nov 2009

• REC opinion

  Further Information Favourable Opinion