Safety and Effectiveness of Bolus Insulin Aspart in People with Type 2 Diabetes: A1chieve Sub-Analysis

Abstract

IntroductionThis sub-analysis evaluated clinical safety and effectiveness of bolus insulin aspart [with/without oral glucose-lowering drugs (OGLDs)] as the only insulin therapy.MethodsA1chieve was an international, multicenter, prospective, open-label, non-interventional, observational, 24-week study in people with type 2 diabetes mellitus starting/switching to biphasic insulin aspart 30, insulin detemir or insulin aspart treatment (alone/in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of bolus insulin aspart (±OGLDs) as the only insulin therapy. Data were analyzed for all patients, insulin-experienced and insulin-naive sub-groups, and sub-groups defined by the number of OGLDs prescribed at baseline (no OGLDs, one OGLD or ≥two OGLDs). Safety and effectiveness endpoints were assessed at baseline and following 24 weeks’ therapy.ResultsIn total, 2,026 patients were included (insulin-experienced, n = 561; insulin-naive, n = 1,465) in this sub-analysis. Significant improvements from baseline after 24 weeks’ treatment with insulin aspart ± OGLDs were observed across all sub-groups for: glycated hemoglobin (range of means across sub-groups −1.6 to −2.4%; p < 0.001 for all comparisons), fasting plasma glucose (−2.5 to −3.8 mmol/l; p < 0.001 for all comparisons), post-breakfast post-prandial glucose (−3.4 to −5.8 mmol/l; p < 0.001 for all comparisons), and health-related quality of life (HRQoL; p < 0.001 for all comparisons). The proportion of patients reporting hypoglycemia events was significantly reduced from baseline after 24 weeks (insulin-naive cohort: 7.9–2.8%; p < 0.001; insulin-experienced cohort: 23.2–7.8%; p < 0.001). There were no reports of major hypoglycemia events at 24 weeks; risk of nocturnal hypoglycemia was <0.6 events/person-year. No serious adverse drug reactions were reported.ConclusionInsulin aspart ± OGLDs is associated with significant improvements in glycemic control and HRQoL, without increased risk of hypoglycemia, in people with type 2 diabetes and sub-optimal glucose control.

Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011

“…ADR information was provided for this study in anonymous form with encrypted identification [8]. Data extraction and data analyses of the raw material were comprehensive and time-consuming.…”

Review of insulin‐associated hypoglycemia and its impact on the management of diabetes in Southeast Asian countries

“…For this reason, both the American Diabetes Association and the European Association for the Study of Diabetes guidelines advise that the target level of glycemic control is individualized based on a patient's risk of hypoglycemia, duration of disease, comorbidities and life expectancy. This individualized approach to treatment translates to hypoglycemia being a common reason for patients with type 2 diabetes changing or switching insulin therapy, and severe cases of hypoglycemia can lead to termination of insulin therapy.…”

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 ].…”