SIBA, Glargine and Insulin Aspart in Type I Diabetes

• Research type

  Research Study

• Full title

  A 52 week randomised, controlled, open label, multicentre, multinational, parallel, treat-to-target trial comparing efficacy and safety of SIBA and insulin glargine both administered once daily in a basal-bolus regimen with insulin aspart as mealtime insulin in subjects with type 1 diabetes.

• IRAS ID

  22813

• Eudract number

  2008-005774-13

• ISRCTN Number

  n/a

• Research summary

  The aim of this study is to compare the blood sugar lowering effect and safety of SIBA (Soluble Insulin Basal Analogue) with that of Insulin Glargine, both in combination with Insulin Aspart, in subjects with Type 1 Diabetes.SIBA, Insulin Glargine and Insulin Aspart are liquids that are administered under the skin (subcutaneous) and will be provided to subjects in injection pens.A planned total of 624 subjects from the following countries will take part in the study: France, Germany, Russia, South Africa, United Kingdom and the United States.Subjects will be asked to attend a total of 20 clinic visits and to be available for 22 telephone contacts during the study. This includes a one week screening period, a treatment period of 52 weeks and a follow up of one week.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/69

• Date of REC Opinion

  24 Jul 2009

• REC opinion

  Further Information Favourable Opinion