LAF237A23152 Triple Therapy: Vildagliptin + Metformin + Glimepiride v1

• Research type

  Research Study

• Full title

  A multi-center, randomized, double-blind placebo controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with type 2 diabetes.

• IRAS ID

  60284

• Contact name

  Daniel McBryan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-021097-11

• ISRCTN Number

  N/A

• Research summary

  Type 2 diabetes mellitus (T2DM) is a chronic progressive disease characterised by hyperglycaemia (high blood sugar). Metformin is the established initial drug for T2DM, sulphonylureas are also common anti-diabetic agents. However treatment with a single anti-diabetic agent is often unsuccessful at achieving and/or maintaining long-term control of blood sugar levels meaning that many patients require combination therapies. The combination of metformin plus a sulphonylurea is a widely used combination therapy.Evidence suggests that many patients on dual combination therapy such as metformin plus a sulphonylurea do not always achieve or maintain control of their blood sugar levels. In this setting the use of insulin is often the next therapeutic step, although the need for daily injections makes this option undesirable for many patients. Triple therapy combinations of oral anti-diabetic therapies are an alternative option. Vildagliptin has been shown to effectively treat T2DM. The actions of vildagliptin are complementary to those of metformin and the safety and efficacy of their combined administration has been shown in previous clinical trials. There is also evidence to show that vildagliptin is effective in combination with sulphonylureas. The aim of this study is to assess the efficacy and tolerability of vildagliptin plus metformin plus glimepiride.Patients that give consent and meet all study eligibility criteria, including a confirmed diagnosis of T2DM and prior concomitant treatment dual or monotherapy will be eligible to enter the study. Participants will be randomised to receive vildagliptin 50 mg bid or matching placebo as add-on therapy to metformin plus glimepiride. Study treatment will last for 24 weeks following a study screening period lasting up to 14 weeks. A total of 290 patients will enter the treatment phase of the study, 20 of which will be from 4 UK sites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/78

• Date of REC Opinion

  17 Nov 2010

• REC opinion

  Further Information Favourable Opinion