LAFB2224 - Vildagliptin Modified Release Dose

• Research type

  Research Study

• Full title

  A multi-centre, randomised, double-blind study to evaluate the efficacy and long-term safety of vildagliptin modified release (MR) as add-on therapy to metformin in patients with type 2 diabetes

• IRAS ID

  12711

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-004722-16

• ISRCTN Number

  n/a

• Research summary

  Type 2 diabetes mellitus (T2DM) is a chronic disease; by 2030 it is expected to affect 370 million people worldwide. Vildagliptin is currently licensed in an immediate release (IR) formulation for the treatment of T2DM. This study is using a modified release (MR) formulation of vildagliptin for the treatment of type 2 diabetes. A lower dose of vildagliptin MR has the potential to provide a similar therapeutic effect to a higher dose of the vildagliptin IR formulation. This study is designed to select an appropriate clinical dose for further development of vildagliptin MR as add-on therapy to metformin as well as evaluate therapeutic effect and safety. Potentially eligible patients will be of 18-78 years with type 2 diabetes and on a stable dose of metformin. Following full informed consent patients will undergo further screening checks in order to confirm their eligibility. Patients will initially be randomised to 1 of 4 arms ?? vildagliptin dose 1 metformin, vildagliptin dose 2 metformin, placebo metformin or sitagliptin metformin. Patients will attend a maximum of 21 study visits over approximately 20 months. The study is being run by Novartis Pharma AG, 2380 patients will enter the study (50 from the UK).

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/7

• Date of REC Opinion

  13 Feb 2009

• REC opinion

  Further Information Favourable Opinion