Sitagliptin compared to liraglutide in patients with type 2 diabetes

• Research type

  Research Study

• Full title

  A Phase III, Multicenter, Randomised, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

• IRAS ID

  71671

• Eudract number

  2010-023759-27

• ISRCTN Number

  N/A

• Research summary

  The aim of this study is to look at the effectiveness and safety of sitagliptin compared to liraglutide in patients with Type 2 diabetes mellitus with inadequate glycaemic control on metformin. Type 2 diabetes is a chronic progressive disease which accounts for more than 90% of all diabetes, and afflicts an estimated 6.6% (284 million) of the adult population worldwide. Despite clinical trials showing that improving glycaemic control reduces the incidence of microvascular complications (e.g., retinopathy and nephropathy), many patients on monotherapy fail to achieve optimal glycaemic control (i.e., levels of glucose which lower the incidence of complications near to that of non-diabetic patients) in part because of inadequate efficacy in glucose lowering, limited durability of glycaemic response, and safety and tolerability issues. In this study approximately 600 patients worldwide will be randomised to receive either sitagliptin or liraglutide over a period of 26 weeks. All patients will continue to take metformin throughout the study. Patients will attend the research clinic on 5 occasions for study related assessments. The pharmaceutical company that's developing sitagliptin is funding the study. It is anticipated that 28 patients from the UK will take part in the study. Patients will be recruited from GP sites.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  11/H0402/6

• Date of REC Opinion

  16 Feb 2011

• REC opinion

  Further Information Favourable Opinion