Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study.

ABSTRACT:

Aim

To compare the safety and efficacy of U500-R delivered by a novel, specifically designed U500-R insulin pump with U-500R delivered by multiple daily injections (MDI).

Methods

The phase 3 VIVID study randomized people with type 2 diabetes to U-500R by continuous subcutaneous insulin infusion (CSII) or MDI. Participants (aged 18-85 years) had HbA1c ≥7.5% and ≤12.0% and a total daily dose of insulin >200 and ≤600 U/day. After a 2-week transition to three times daily injections of U-500R, participants were treated for 24 weeks with U-500R by CSII or MDI. Treatment arms were compared using mixed model repeated measures analysis.

Results

The study randomized 420 participants (CSII: 209, MDI: 211) with 365 completers. Mean changes from baseline were: HbA1c, -1.27% (-13.9

SUBMITTER: Grunberger G 

PROVIDER: S-EPMC7065168 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature