Safety and Effectiveness of Insulin Aspart in Basal-Bolus Regimens Regardless of Age: A1chieve Study Results

Abstract

IntroductionHypoglycemia is a complication in the management of type 2 diabetes, and elderly people are at greater risk of experiencing hypoglycemia events than younger patients. Insulin analogs achieve glycemic control with minimal risk of hypoglycemia and may therefore be a good treatment option for all patients.MethodsA1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who started/switched to therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone/in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of insulin aspart as part of a basal-bolus regimen (±oral glucose-lowering drugs) in three age-groups (≤40, >40–65, and >65 years) of insulin-experienced and insulin-naive people with type 2 diabetes.ResultsIn total, 4,032 patients were included in the sub-analysis. After 24 weeks of insulin aspart treatment, significant improvements versus baseline were observed in all age-groups for: proportion of people with ≥1 hypoglycemia events (18.3–27.1% and 11.0–12.7%, at baseline and 24 weeks, respectively), ≥1 major hypoglycemia events (3.3–6.7% and 0–0.2%), and ≥1 nocturnal hypoglycemia events (9.2–13.7% and 2.9–4.9%); glycated hemoglobin (9.6–9.8% and 7.4%); fasting plasma glucose (change from baseline ranged from −3.6 to −4.4 mmol/l); and post-breakfast post-prandial plasma glucose (change from baseline ranged from −5.5 to −5.9 mmol/l). Fourteen serious adverse drug reactions were reported. Health-related quality of life was significantly improved for all age-groups (all, p < 0.001).ConclusionAll age-groups showed improved glycemic control and reduced risk of hypoglycemia when starting/switching to insulin aspart therapy within a basal-bolus regimen; this may be particularly important for elderly patients given their greater risk of hypoglycemia versus younger patients.

AUTONOMY: The First Randomized Trial Comparing Two Patient-Driven Approaches to Initiate and Titrate Prandial Insulin Lispro in Type 2 Diabetes

“…The efficacy and safety of treatment intensification in the elderly is critical because of the aging population and higher prevalence of type 2 diabetes in this group (23). These findings are consistent with those of the A 1 chieve study and show that a basalbolus therapy can be initiated in the elderly without increased risk of hypoglycemia (24). Moreover, in a pooled analysis, Lee et al (25) described that adding insulin GLA in an elderly patient population had low rates of hypoglycemia with decreases in HbA 1c similar to those in younger patients; however, AUTONOMY expanded on these results to demonstrate that therapy intensification and self-titration, starting with a single prandial dose of lispro, can safely occur in the elderly.…”

When basal insulin is not enough: successful strategies for insulin intensification in patients with type 2 diabetes mellitus

“…В данном исследовании первая инъекция прандиального инсулина вводилась перед за-втраком и в дальнейшем, при необходимости, пациентам добавлялась 2-я или 3-я инъекция перед обедом и ужином, титрация осуществлялась по уровню гликемии перед сле-дующим приемом пищи. Результаты этого исследования согласуются с ранее представленными данными [26] о том, что стратегия постепенного добавления прандиального инсулина к базальному может безопасно использоваться у категории пожилых пациентов с СД2, поскольку в ис-следовании AUTONOMY в подгруппе пациентов ≥65 лет инициация терапии прандиальным инсулином не проде-монстрировала повышения риска развития гипогликеми-ческих реакций [24]. В данном исследовании у пациентов имело место увеличение массы тела независимо от того, какой алгоритм титрации использовался; однако в груп-пе пациентов, проводивших титрацию инсулина раз в три дня (Q3D), была отмечена несколько большая прибавка массы тела.…”

“…В этой стратегии также использованы общие принци-пы самостоятельного измерения глюкозы крови натощак перед завтраком, минимизируя таким образом потреб-ность в дополнительных точках самоконтроля в течение дня. Еще одним преимуществом данного подхода являет-ся удобство выполнения инъекции в домашних условиях, что позволяет пациентам контролировать гликемию на-тощак утром с целью улучшения гликемического контро-ля в течение дня [26]. Как и в исследованиях AUTONOMY и FullSTEP, в исследовании START пациентам перед добав-лением инъекций прандиального инсулина были оптими-зированы дозы базального инсулина [27].…”

Insulin Aspart in the Management of Diabetes Mellitus: 15 Years of Clinical Experience

“…In two large observational studies, HbA 1c , PPG and fasting plasma glucose (FPG) levels were significantly reduced after switching to insulin aspart, one in which patients used insulin aspart with a basal insulin [ 87 ], and another in which basal insulin was not used [ 88 ]. In both studies, oral antidiabetic drugs (OADs) were allowed.…”

“…The A 1 chieve observational study in patients who started or switched to basal–bolus therapy with insulin aspart has demonstrated reduced risk of hypoglycemia in people aged ≤40, 40–65, and >65 years [ 87 ] (Table 4 b). Another analysis of the A 1 chieve study, examining 2026 patients using insulin aspart as the only insulin treatment, indicated that both insulin-naïve and insulin-experienced patients had reduced risk of overall hypoglycemia after adding insulin aspart to their treatment regimen [ 88 ].…”