NN1250-3672 BEGIN: Low Volume

• Research type

  Research Study

• Full title

  A 26-week randomised, confirmatory, controlled, open label, multicentre, multinational treat-to-target trial comparing the efficacy and safety of soluble insulin basal analogue (SIBA) 200 U/ml and insulin glargine, both injected once daily in combination with oral anti-diabetic drugs (OADs), in insulin naïve subjects with type 2 diabetes mellitus currently treated with OAD(s) qualifying for intensified treatment

• IRAS ID

  37232

• Contact name

  Martin Gibson

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2009-010662-28

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The aim of this study is to compare the gloucose lowering effect of Soluble Insulin Basal Anallogue (SIBA) 200 U/ml with that of insulin glargine both in combination with metformin a DPP4 inhibitor in Type 2 diabetic patients who need to start insulin. In UK DPP4 inhbitors are not licensed for use with insulin so if subjects are taking these on entry to the study these will be stopped at randomisation (along with any other OADs, apart from metformin).A planned total of 450 patients from the following countries will take part: France, Ireland, United Kingdom, Russia, Ukraine, South Africa, Canada and United States of America.Subjects will be asked to attend a total of 15 clinic visits and 14 telephone contacts during the study. This includes a 1 week screening period, a 26 week treatment period and a 1 week follow up period.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/81

• Date of REC Opinion

  20 Jan 2010

• REC opinion

  Further Information Favourable Opinion