LAF237A23135: add-on to insulin with or without metformin v1

• Research type

  Research Study

• Full title

  A 24-week, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of vildagliptin 50mg bid as an add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus

• IRAS ID

  60283

• Contact name

  Daniel McBryan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-020684-20

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Type 2 diabetes mellitus (T2DM) is a chronic progressive disease characterised by hyperglycaemia (high blood sugar). The prevalence of T2DM is expected to reach 370 million affected individuals worldwide by the year 2030. The associated long-term complications that affect morbidity and mortality are therefore a global public health concern.'Diet and exercise' is often the first line treatment for T2DM but success rates are limited. Metformin is considered to be the first line drug therapy for T2DM however a signficant number of patients are unable to tolerate it or do not achieve glycaemic control on maximum tolerated doses. Insulin therapy has been shown to improve glycaemic control in T2DM either alone or in combination with metformin treatment. However many patients are unable to achieve adequate glycaemic control on insulin regimens.Vildagliptin has previously 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. It is hope that this study will confirm that vildagliptin treatment is also complementary to insulin therapy.Patients that give consent to participate and meet all study eligibility criteria, including a confirmed diagnosis of T2DM and prior concomitant treatment with insulin, with or without metformin will be eligible to enter the study. Participants will be randomised to receive vildagliptin 50 mg twice daily or matching placebo as add-on therapy to their current insulin/insulin metformin treatment. Study treatment will last for 24 weeks following a study screening period of two weeks. A total of 428 patients will enter the treatment phase of the study, 20 of which will be from 5 UK sites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/79

• Date of REC Opinion

  17 Nov 2010

• REC opinion

  Further Information Favourable Opinion