NN1250-3725 Basal Bolus in Type I Diabetes. Extension to NN1250-3585.

• Research type

  Research Study

• Full title

  A 26-week controlled, open labelled, multinational, multicentre, two arm, parallel, treat-to-target extension trial comparing safety and efficacy 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 after a preceeding 26 week treatment period in trial NN1250-3585 with SIBA or insulin detemir both with mealtime insulin aspart.

• IRAS ID

  49736

• Contact name

  Doctor Marc Evans

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2009-015721-36

• 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, over a period of 12 months. The extension of the trial, to include a 12 month treatment period, is expected to be sufficient to confirm the long term safety of treatment with SIBA in combination with Aspart. SIBA, insulin Detemir and insulin Aspart are liquids that are administered under the skin (subcutaneous) and will be provided to subjects in injection pens. All subjects who complete the 6 month treatment period of NN1250-3585 will be invited to participate. It is expected that approximately 360 subjects will complete 1250-3585 and that approximately 306 of them will enter the extension. The following countries will take part in the study: Brazil, Finland, India, Italy, Japan, Macedonia and UK. Subjects will be asked to attend a total of 8 clinic visits and to be available for 7 telephone contacts during the study. This includes a screening visit on the same day as V29 of trial NN1250-3585 and a follow up visit after discontinuing the trial treatment.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/24

• Date of REC Opinion

  22 Apr 2010

• REC opinion

  Favourable Opinion