Other
English
ID: <
10670/1.o87qpg>
·
DOI: <
10.26226/morressier.5d9b6229ea541d6ca849388a>
Abstract
Background: ACHIEVE Control was a large (N=3304) randomized, prospective, open-label, pragmatic real-life study comparing the efficacy and safety of insulin glargine 300 U/mL (Gla-300) versus other standard of care basal insulins (SOC-BI) in insulin-naive patients with T2D. The trial demonstrated superiority of Gla-300 in the primary composite endpoint of individualized A1C target attainment (<8% for patients aged u226565 years or with defined comorbidities; <7% for all other patients) without documented symptomatic (blood glucose [BG] u226470 mg/dL) or severe hypoglycaemia at any time of day from baseline to 6 months. Aims: Older patients are typically more vulnerable to hypoglycaemia and its adverse consequences. This ad-hoc subanalysis assessed the likelihood of attaining individualized A1C targets without symptomatic documented and/or severe anytime hypoglycaemia after 6 and 12 months, according to age.Methods: Patients aged u226518 years with T2D (A1C 8u201311%) who were insulin-naive and under the care of their physician for u22651 year before the index date were randomized to Gla-300 or SOC-BI. Outcomes at 6 and 12 months were compared for Gla-300 versus SOC-BI according to three age categories: <65 years; 65u2013<75 years; u226575 years; endpoints included: a) composite endpoints (A1C target attainment without severe and/or documented symptomatic hypoglycaemia), b) A1C target attainment regardless of hypoglycaemia, and c) hypoglycaemia avoidance (without severe and/or documented symptomatic hypoglycaemia).Results: Age, gender, body weight, BMI and A1C were well balanced between treatment arms for all age categories. At 6 and 12 months, in the older age subgroups (65u2013<75 years; u226575 years), a higher percentage of patients who received Gla-300 achieved individualized A1C target without severe and/or documented symptomatic hypoglycaemia (at both BG u226470 and <54 mg/dL) compared with those who received SOC-BI (Table). Higher percentages of patients aged 65u2013<75 years (at 6 and 12 months) and u226575 years (at 12 months) who received Gla-300 achieved A1C target regardless of hypoglycaemia compared with SOC-BI (Table). At 6 and 12 months, fewer patients in older age groups who received Gla-300 experienced severe and/or documented symptomatic hypoglycaemia (at both BG u226470 mg/dL and <54 mg/dL cut-offs) compared with those who received SOC-BI (Table).Discussion: These exploratory results suggest that the efficacy benefit and reduction in hypoglycaemia rate demonstrated by Gla-300 over SOC-BIs in the overall ACHIEVE Control study population would be maintained in patients aged 65u2013<75 years and u226575 years. Therefore, Gla-300 may provide benefit for hypoglycaemia avoidance in older T2D patients.