DAPA 10 - Dapagliflozin add on to sitagliptin plus metformin

• Research type

  Research Study

• Full title

  A 24 week, multicentre, randomised, double-blind, placebo-controlled, parallel-group, international phase III study with a 24-week extension period to evaluate the safety and efficacy of Dapagliflozin 10mg daily in patients with type 2 diabetes who have inadequate glycaemic control on a DPP-4 inhibitor (Sitagliptin) alone or in combination with Metformin

• IRAS ID

  28064

• Contact name

  Bhavesh Bodalia

• Sponsor organisation

  AstraZeneca

• Eudract number

  2009-012806-37

• ISRCTN Number

  N/A

• Research summary

  In type 2 diabetes the level of blood sugar is above normal. Since many patients with type 2 diabetes do not achieve treatment goals with current therapies, there is a need for new treatments, especially those that do not cause low blood sugar or weight gain. Dapagliflozin is an experimental drug that works differently than other known drugs: it causes sugar from the blood to be excreted in the urine. This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied. Approximately 430 patients from North and South America and three European countries will take part. About fifty patients will be recruited from the UK. Men and women aged 18 years or older with type 2 diabetes may be eligible. Only patients who are not receiving treatment for type 2 diabetes, or those who currently receive metformin, sitagliptin or vildagliptin can be enrolled. Eligible patients will be screened by a blood test and only those who need additional therapy will be enrolled. Patients in the study will be divided into two groups. Both groups will receive background drug treatments but in only one group (50% of all patients) dapagliflozin will be added on to background treatment. The other group will receive an inactive placebo pill. There are fourteen study visits over a one year and three months period. At the visits patients will be asked to give blood samples for routine blood tests. At three visits during the study, blood samples will be taken before and after a liquid meal to compare blood sugar before and after meals. Other assessments will include urine tests, ECG, and physical examinations.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  09/H1211/90

• Date of REC Opinion

  4 Nov 2009

• REC opinion

  Favourable Opinion