CLAF237A23150: vildagliptin treatment for T2DM in the elderly v1

• Research type

  Research Study

• Full title

  A multi-centre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin in type 2 diabetes mellitus patients = 70 years (drug-naive or inadequately controlled on oral agents)

• IRAS ID

  71319

• Contact name

  William David Strain

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-022658-18

• ISRCTN Number

  finished

• Research summary

  Type 2 diabetes mellitus (T2DM) is a chronic progressive disease characterised by hyperglycaemia (high blood sugar). It is common in the elderly which currently represents half of the diabetic population, and elderly patients represent the largest growing population in T2DM.Treatment of T2DM in the elderly is complicated, hypoglycaemia (low blood sugar) as a result of treatment for T2DM is the most serious potential complication encountered. Patients may also suffer from several other conditions alongside T2DM, resulting in treatment with multiple medications. These factors mean than over 50% of the elderly population with T2DM do not achieve ultimate glycaemic control (control of their blood sugar level). There is therefore a need for additional effective and well-tolerated treatment options for elderly patients with T2DM. Vildagliptin is proved to be well-tolerated and improve glycaemic control when given as monotherapy or in combination with metformin, sulphonylureas (SU) or thiazolidinediones (TZD) or insulin. Data from previous studies shows that there is a reduction in fasting plasma glucose (FPG) and HbA1c (tests used to measure T2DM) and in hypoglycaemic events in patients treated with vildagliptin. This study is designed to provide additional data on the safety and efficacy of vildagliptin in elderly patients with T2DM. The data will be used to provide more experience with vildagliptin in an elderly population. Patients over 70 years of age with a diagnosis of T2DM that give consent and meet all study eligibility criteria will be eligible to enter the study. Participants will receive vildagliptin or matching placebo in addition to any previously prescribed oral anti-diabetic treatment, if any. Study treatment will last for 24 weeks following a screening period of up to 2 weeks. A total of 280 patients will enter the treatment phase of the study, 35 of which will be from 5 UK sites.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  11/EE/0029

• Date of REC Opinion

  11 Apr 2011

• REC opinion

  Further Information Favourable Opinion