NN1250-3585 BEGIN Basal Bolus in Type I Diabetes. SIBA verses Levemir

• Research type

  Research Study

• Full title

  A 26-week confirmatory, randomised, controlled, open label, multicentre, multinational, parallel, treat-to-target trial comparing efficacy and safety of Soluble Insulin Basal Analogue (SIBA) and insulin detemir in a basal-bolus regimen with insulin aspart as mealtime insulin in subjects with type 1 diabetes mellitus.

• IRAS ID

  37291

• Contact name

  Doctor Marc Evans

• Sponsor organisation

  Novo Nordisk

• Eudract number

  2009-011672-29

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  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 detemir, both in combination with insulin aspart, in subjects with Type 1 Diabetes.SIBA, insulin detemir 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 426 subjects from the following countries will take part in the study: Argentina, Brazil, Finland, India, Italy, Japan and Macedonia.Subjects will be asked to attend a total of 15 clinic visits and to be available for 14 telephone contacts during the study. This includes a one week screening period, a treatment period of 26 weeks and a follow up of one week.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/116

• Date of REC Opinion

  20 Jan 2010

• REC opinion

  Further Information Favourable Opinion