BIAsp-3878: Investigator driven vs subject driven titration of BIAsp30

• Research type

  Research Study

• Full title

  A 20 weeks randomised, multinational, open labelled, 2 armed, parallel group comparison of twice daily subject-driven titration of biphasic insulin aspart (BIAsp) 30 versus twice daily investigator-driven titration of biphasic insulin aspart (BIAsp) 30 both in combination with metformin in subjects with type 2 diabetes inadequately controlled on basal insulin analogues.

• IRAS ID

  76213

• Contact name

  Gerrard Rayman

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2010-024303-27

• ISRCTN Number

  not known

• Research summary

  This study is to examine the efficacy and safety of two different methods of managing treatment using Biphasic insulin aspart (BIAsp) 30 in inadequately controlled patients with type 2 diabetes currently treated with a basal insulin analogue, with or without other antidiabetic tablet treatment. The study is multinational, open labelled, 2 armed with a parallel group design. All patients will receive the same treatment (BIAsp 30) but the way in which insulin dose will be adjusted (titration) will be different. The study compares subject-driven titration with investigator-driven titration.The drug is currently available on the market. BIAsp30 obtained marketing authorisation by the European Commission in August 2000. The titration guidelines that will be followed are as per the approved guidelines.In total, 338 patients with type 2 diabetes will take part in the study and receive study medication. 30 of the these patients will be enrolled into the study in the UK. It is expected that 286 patients will complete the study, which will last 22 weeks.It is anticipated that there will be some direct benefit to patients due to the positive experience of participating in a clinical trial. It may also be expected that some patients will benefit in both the short and long term through the intensification of their diabetes therapy and any associated improvement in glycaemic control.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  11/LO/0887

• Date of REC Opinion

  5 Aug 2011

• REC opinion

  Further Information Favourable Opinion