SIAC, insulin detemir and insulin aspart in type 1 diabetes
Research type
Research Study
Full title
A 26-week, multinational, multi-centre, open-labelled, two-arm, parallel, randomised, treat-to-target trial comparing the efficacy and safety of soluble insulin analogue combination (SIAC) once daily plus meal-time insulin aspart for the remaining meals vs. basal-bolus treatment with insulin detemir plus meal-time insulin aspart in subjects with type 1 diabetes
IRAS ID
24069
Eudract number
2008-005769-71
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research summary
The aim of this study is to confirm both the safety and ability to control blood sugar levels by treatment with a new insulin product called SIAC (Soluble Insulin Analogue Combination) in people with type 1 diabetes. In this research study, SIAC (a combination of both short and long acting insulins) is injected with the main meal of the day, while a marketed short acting insulin (insulin aspart) is injected at the other two mealtimes. The blood sugar controlling effect of this treatment regimen is compared to a commonly used treatment regimen of long acting insulin (insulin detemir) injected once a day in the evening, along with the short acting insulin (insulin aspart) at each of the three mealtimes.All insulins are liquids administered by subcutaneous (under the skin) injection and will be provided to patients in injection pens.A total of 528 subjects with Type 1 diabetes from the following countries will participate in the study: Denmark, Poland, Romania, France, United Kingdom, Russian Federation, Israel, Australia and the United States.Subjects will be asked to attend a total of 15 clinic visits and be available for 14 telephone contacts during the study. This includes a one week screening period, a treatment period of 26 weeks and a follow-up of one week.
REC name
North West - Haydock Research Ethics Committee
REC reference
09/H1010/34
Date of REC Opinion
9 Jul 2009
REC opinion
Further Information Favourable Opinion