IntroductionDiabetes therapy should balance glycemic control with risk of adverse events. This sub-analysis of the A1chieve study evaluated clinical safety and effectiveness of insulin detemir in different age-groups (≤40 years, >40–65 years, and >65 years) of insulin-experienced and insulin-naïve people with type 2 diabetes.MethodsA1chieve was an international, open-label, non-interventional, 24-week study in 66,726 people with type 2 diabetes starting/switching 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 in patients starting/switching to insulin detemir (±oral glucose-lowering drugs).ResultsIn total, 15,241 patients were included in the sub-analysis. In all age-groups, the proportion of participants experiencing any, major or nocturnal hypoglycemia was significantly (all p < 0.05) reduced relative to baseline, except in insulin-naïve patients for any and nocturnal hypoglycemia, where there was a significant increase or no significant change in patients aged >65 years and >40–65 years, respectively, and no significant change in major hypoglycemia in insulin-naïve patients aged ≤40 years. Seven serious adverse drug reactions were reported. Body weight was significantly reduced in patients aged ≤40 years and >40–65 years and significantly increased in insulin-naïve patients aged >65 years at 24 weeks. At 24 weeks, glycated hemoglobin was reduced by 2.3%, 2.0%, and 1.8%, in the ≤40 years, >40–65 years, and >65 years age-groups, respectively (all p < 0.001). Fasting and post-prandial plasma glucose were significantly reduced and health-related quality of life (HRQoL) significantly improved across all patient cohorts (all p < 0.001).ConclusionAfter 24-week treatment with insulin detemir, all age-groups of insulin-experienced and insulin-naïve patients had significantly improved glycemic control and HRQoL. The proportion of patients experiencing hypoglycemia was reduced in all age-groups but unchanged in insulin-naïve patients aged >40–65 years and increased in insulin-naïve patients aged >65 years. The safety and effectiveness of insulin detemir may benefit all age-groups.
People with type 2 diabetes in poor glycaemic control starting treatment with insulin detemir reported significant improvements in glycaemic control with improved treatment tolerability, irrespective of prior treatment and geographical region, after 24 weeks.
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.
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