ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2013
Safety and effectiveness of bolus insulin aspart in people with type 2 diabetes: a1chieve sub-analysis.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00869908 (The Effect of NovoMix® 30, Levemir® or NovoRapid®), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Study
Who cites it
4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.
- Health state utility values of type 2 diabetes mellitus and related complications: a systematic review and meta-regression.Health and quality of life outcomes · 2024Pooled it
- Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis.BMC endocrine disorders · 2015Pooled it
- Review of insulin-associated hypoglycemia and its impact on the management of diabetes in Southeast Asian countries.Journal of diabetes investigation · 2017Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.