Dataset Information

Safety and effectiveness of insulin detemir in different age-groups in the a1chieve study.

ABSTRACT:

Introduction

Diabetes 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.

Methods

A1chieve 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).

Results

In 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).

Conclusion

After 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.

SUBMITTER: Malek R

PROVIDER: S-EPMC3687092 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionEffective management of type 2 diabetes requires sustained glycemic control over many years, which can be particularly challenging for elderly people. This sub-analysis of the A1chieve study evaluated the clinical safety and effectiveness of biphasic insulin aspart 30 in 3 age-groups (≤40, >40-65, and >65 years) of previously insulin-experienced and insulin-naïve people with type 2 diabetes.MethodsA1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who had been receiving anti-diabetes medication before starting, or switching to, therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of biphasic insulin aspart 30 (±oral glucose-lowering drugs) in different age-groups.ResultsData on 40,122 participants were included. In all age-groups, the proportion of participants experiencing any hypoglycemia, major hypoglycemia or nocturnal hypoglycemia was significantly reduced from baseline, except for the following in insulin-naïve patients: a significant increase in any hypoglycemia in patients aged >65 years; no change in any hypoglycemia, major hypoglycemia, and nocturnal hypoglycemia in patients aged >40-65, ≤40, and >65 years, respectively. Significant improvements at 24 weeks vs. baseline were observed in insulin-experienced and insulin-naïve participants for: glycated hemoglobin (change from baseline ranged from -1.8% to -2.4%); fasting plasma glucose (from -3.0 to -4.3 mmol/l); post-breakfast post-prandial plasma glucose (from -4.1 to -6.5 mmol/l); and health-related quality of life (HRQoL). Sixteen serious adverse drug reactions were reported.ConclusionAfter 24-week treatment with biphasic insulin aspart 30, all age-groups of insulin-experienced and insulin-naïve patients experienced significantly improved glycemic control and HRQoL; incidence of hypoglycemia was generally reduced. The tolerability and effectiveness of biphasic insulin aspart 30 may benefit all age-groups.

Project description: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.

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