NN1250-3724: BEGIN™: EASY AM

• Research type

  Research Study

• Full title

  A 26 week randomised, confirmatory, controlled, open label, multicentre, multinational, treat to target trial comparing efficacy and safety SIBA 200 U/ml three times weekly injected in the morning and insulin glargine once daily in a population of insulin naive subjects with type 2 diabetes mellitus currently treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.

• IRAS ID

  38425

• Contact name

  Prakash Abraham

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2009-011398-33

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The aim of this study is to observe the blood sugar lowering effect of SIBA (Soluble Basal Insulin Analogue) given by injection three times a week (on a Monday, Wednesday and Friday) after 26 weeks of treatment in patients with type 2 diabetes. This will be compared to the effect of 26 weeks of daily treatment with another treatment group with daily Insulin Glargine given by injection at the same time on a daily basis for 26 weeks. Insulin Glargine has been chosen as a comparator since it is safe and widely used insulin. Patients entering this study are not currently taking insulin but are being treated with oral anti-diabetic tablets. They will not have adequate blood sugar control and it has been proven that early addition of insulin significantly improves blood sugar control. The objective of the study is to confirm that SIBA provides glycaemic control at least as effective as the treatment with Insulin Glargine. A total of 450 patients from the following countries will take part in the study (taking trial medication): UK, Canada, Czech Republic, Israel, Slovakia, South Africa and USA. Patients 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 1 week screening period, a treatment period of 26 weeks and a follow up period of 1 week.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/78

• Date of REC Opinion

  1 Feb 2010

• REC opinion

  Further Information Favourable Opinion