D1690R00009: The DECIDE Study
Research type
Research Study
Full title
Pragmatic Randomised 104 Week Multicentre Trial to Evaluate the Comparative Effectiveness of dapagliflozin and Standard of Care in Type 2 Diabetes. The DECIDE Study.
IRAS ID
183832
Contact name
Kamlesh Khunti
Contact email
Sponsor organisation
AstraZeneca Farmacéutica Spain, S.A.
Eudract number
2015-001873-42
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
DECIDE is a 104 week multicentre trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between Forxiga (dapagliflozin) and Standard of Care (SOC).
Forxiga (dapagliflozin) is a drug and which in previous scientific studies has been shown to be safe and to improve diabetes management. This study is being carried out to confirm Forxiga’s effectiveness and tolerability in treating diabetes when used in everyday practice. To do this, Forxiga will be compared with the standard of care treatments. Medications that will be used in this study are all ones that are currently prescribed in the UK. The study will help doctors to decide whether Forxiga is a suitable long-term treatment for patients with type 2 diabetes who have not been able to manage on other drugs, when used in real life practice.
Approximately 880 patients will take part in this study in the United Kingdom. The study will last 2 years. The study will include information provided by participating patients through questionnaires, as well as information from routine health check-ups collected from electronic medical records.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0430
Date of REC Opinion
27 Oct 2015
REC opinion
Further Information Favourable Opinion