NN1250-3644 BEGIN™ : T1 diabetes, extension study to NN1250-3583
Research type
Research Study
Full title
A 52 week controlled, open label, multicentre, multinational, two-arm, parallel, treat-to-target extension trial comparing the safety and efficacy of SIBA and insulin glargine both administered once daily in a basal-bolus regimen with insulin aspart as mealtime insulin in subjects with type 1 diabetes after a preceding 52 week treatment period in trial NN1250-3583 with SIBA or insulin glargine both with mealtime insulin aspart
IRAS ID
47666
Contact name
David Russell-Jones
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2009-015755-24
ISRCTN Number
n.a
Clinicaltrials.gov Identifier
n.a
Research summary
The aim of this study is to investigate the long term safety and tolerability of a new insulin product called SIBA (Soluble Insulin Basal Analogue) in people with Type I diabetes.
This study is a 52 week extension to the ongoing NN1250-3583 study, in which the blood sugar lowering effect and safety of SIBA is being compared with that of insulin glargine, both being administered with insulin aspart.
SIBA, insulin glargine and insulin aspart are all liquids that are administered by injection under the skin (subcutaneous) and will be provided to study subjects in injector pens.
In the extension study, subjects will continue to receive either SIBA once daily plus insulin aspart or insulin glargine plus insulin aspart as previously randomly allocated in the NN1250-3583 study.
A planned total of 396 subjects with Type 1 diabetes from France, Germany, Russia, South Africa, United Kingdom and the United States will take part in the study but the actual total will depend on a) the total number of subjects that complete the main NN1250-3583 study and b) the number of completers of the main study that consent to the extension study.
During this extension study, subjects will be asked to attend a total of 15 clinic visits and to be available for 14 telephone contacts. The screening visit will take place on the same day as the last visit in the main study, after which there is a one week screening period, followed by a treatment period of 52 weeks and a final follow up of one week.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
10/H0305/17
Date of REC Opinion
18 May 2010
REC opinion
Further Information Favourable Opinion