Insulina regular U-500 en infusión continua vs inyecciones en dosis múltiples en adultos con diabetes tipo 2
Grunberger G, Bhargava A, Ly T, et al. Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study. Diabetes Obes Metab. 2020 Mar;22(3):434-441. doi: 10.1111/dom.13947. Epub 2020 Jan 26. (Original study)
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 < 0.001). Weight changes and rates of documented symptomatic and severe hypoglycaemia were similar between groups; the CSII group had a higher rate of nocturnal hypoglycaemia.
CONCLUSIONS: In type 2 diabetes requiring high doses of insulin, both methods of U-500R delivery lowered HbA1c. However, the CSII group attained greater HbA1c reduction with significantly less insulin. Individualized dose titration will be important to balance glycaemic control with hypoglycaemia risk.