SAXA TOT - Saxagliptin Triple Oral Therapy Study

• Research type

  Research Study

• Full title

  A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with the Combination of Metformin and Sulfonylurea

• IRAS ID

  47508

• Contact name

  Michael Butler

• Sponsor organisation

  AstraZeneca

• Eudract number

  2010-019428-30

• ISRCTN Number

  N/a

• Research summary

  Type 2 diabetes 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 type 2 diabetes do not reach adequate blood glucose control when taking combination therapy with metformin and sulphonylurea (both are well established treatments for type 2 diabetes). The addition of another glucose lowering medicine with a different mechanism of action might show benefits. Saxagliptin (study drug) is a medication that increases the levels of GLP1 (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 combination therapy of metformin and sulphonylurea is more efficacious than placebo in patients who have type 2 diabetes with inadequate glycaemic control. Patients will be randomly allocated to an add on treatment of saxagliptin or placebo on top of their existing double-combination treatment. The study will be conducted in five countries across Asia Pacific and Europe. Patients will be in the study for 26 weeks and will be required to attend 9 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 data will also be collected to check that treatment with saxagliptin is safe and well tolerated in patients who have type 2 diabetes.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/29

• Date of REC Opinion

  5 May 2010

• REC opinion

  Further Information Favourable Opinion