Saxagliptin vs glimepiride in T2diabetic patients 65+ yrs (GENERATION)

• Research type

  Research Study

• Full title

  A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy.

• IRAS ID

  28017

• Contact name

  Ronald Pieters

• Sponsor organisation

  AstraZeneca

• Eudract number

  2009-012816-41

• ISRCTN Number

  n/a

• Research summary

  Type 2 diabetes is caused by the underproduction of insulin from beta cells in the pancreas and inefficient action on the target organs. Insulin is needed for glucose to move from the blood into the body'so reduced insulin levels and/or action leads to higher blood glucose (hyperglycaemia). Type 2 diabetes is increasingly common in the elderly, however the currently available treatments are not always well tolerated in the older patient. Elderly patients may not be receiving the best medications for their diabetes and may be at higher risk of hypoglycaemia resulting from the use of some oral agents. Saxagliptin is a new investigational drug being developed for the treatment of type 2 diabetes. Saxagliptin may lower the blood glucose level by stopping the breakdown of a hormone in the body called Glucagon-Like Peptide 1 (GLP 1). GLP-1 helps to release insulin when your blood glucose level is high. This study is being done to see if saxagliptin is effective and safe in treating type 2 diabetes in elderly patients and also how it compares to another approved diabetic medication often prescribed, glimepiride. All patients who enter the study will be having their diabetes treated with a medicine called metformin and will continue to take this. Patients will be randomly allocated to a treatment of saxagliptin or glimepiride on top of their usual metformin. Approximately 700 patients aged 65 years old and over from several European countries will take part; about 80 patients from the UK. The treatment will last for 52 weeks. Patients will attend a screening visit and 11 clinic visits. During these visits the patient??s blood glucose level will be measured to assess their response to treatment and for routine safety blood tests.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/99

• Date of REC Opinion

  13 Oct 2009

• REC opinion

  Further Information Favourable Opinion