Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension.

ABSTRACT:

Objective

This study investigated the efficacy and safety of insulin degludec (IDeg) once daily (OD), varying injection timing day to day in subjects with type 1 diabetes.

Research design and methods

This 26-week, open-label, treat-to-target, noninferiority trial compared IDeg forced flexible (Forced-Flex) OD (given in a fixed schedule with a minimum 8 and maximum 40 hours between doses) with IDeg or insulin glargine (IGlar) given at the same time daily OD. In the 26-week extension, all IDeg subjects were transferred to a free-flexible (Free-Flex) regimen, which allowed any-time-of-day dosing, and compared with subjects continued on IGlar.

Results

After 26 treatment weeks, mean glycosylated hemoglobin was reduced with IDeg Forced- Flex (-0.40%), IDeg (-0.41%), and IGl

SUBMITTER: Mathieu C 

PROVIDER: S-EPMC3612802 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature