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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?mmol/mol) with CSII and?-0.85% (-9.3?mmol/mol) with MDI (difference?-?0.42% [-4.6?mmol/mol], P <0.001); fasting plasma glucose, -33.9?mg/dL (-1.9?mmol/L) with CSII and 1.7?mg/dL (0.09?mmol/L) with MDI (difference?-?35.6?mg/dL [-2.0?mmol/L], P <0.001); total daily dose, 2.8?U with CSII and 51.3?U with MDI (P

SUBMITTER: Grunberger G 

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

REPOSITORIES: biostudies-literature

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

Grunberger George G   Bhargava Anuj A   Ly Trang T   Zisser Howard H   Ilag Liza L LL   Malone James J   Fan Ludi L   Zhang Shuyu S   Johnson Jennal J  

Diabetes, obesity & metabolism 20200126 3


<h4>Aim</h4>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).<h4>Methods</h4>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  ...[more]

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