NN1250-3770 - The SIBA Flex 1 Study

• Research type

  Research Study

• Full title

  A 26 week, randomised, controlled, open label, multicentre, multinational, three-arm, parallel, treat-to-target trial comparing efficacy and safety of two different dosing regimens of SIBA and one dosing regimen of insulin glargine, both in combination with meal-time insulin aspart in subjects with type 1 diabetes mellitus.

• IRAS ID

  37307

• Contact name

  Elemer Balogh

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2009-012923-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The aim of this study is to observe the blood sugar lowering effect of SIBA (Soluble Basal Insulin Analogue) given in a daily flexible dosing regimen after 26 weeks of treatment in patients with type 1 diabetes. This will be compared to the effect of 26 weeks of daily treatment with SIBA given in a fixed dosing regimen in the evening and also with another treatment group with daily Insuln Glargine given at the same time on a daily basis for 26 weeks. All patients will also receive insulin aspart as their bolus insulin treatment at mealtimes.In the flexible dosing arm patients will be asked to inject SIBA on Monday, Wednesday and Friday mornings and also on Tuesday, Thursday, Saturday and Sunday evenings. The morning period is defined as the time from waking up until the first meal of the day and the evening period is defined as the time period from the start of the main evening meal until bedtime.The objective of the study is to analyse if the SIBA flexible dosing arm provides glycaemic control as effective as the fixed treatment arms with Insulin Glargine given at the same time on a daily basis and SIBA given in the evening in the fixed arm.A total of 486 patients from the following countries will take part in the study:Belgium, Germany, Greece, Norway, Poland, United Kingdom, United States of America.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

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/144

• Date of REC Opinion

  22 Jan 2010

• REC opinion

  Further Information Favourable Opinion