Trial reportJournal of diabetes science and technology2013
Understanding heterogeneity in response to antidiabetes treatment: a post hoc analysis using SIDES, a subgroup identification algorithm.
Trial report in Journal of diabetes science and technology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Identification of Diabetes Mellitus Subtypes Applying Cluster Analysis Techniques: A Systematic Review.International journal of environmental research and public health · 2020Pooled it
- Clinical Characteristics and Complication Profiles of Patients Classified According to Cluster-Derived Diabetes Phenotypes.Medicina (Kaunas, Lithuania) · 2026Article
- The Combined Effect of Neuromuscular Electrical Stimulation and Insulin Therapy on Glycated Hemoglobin Concentrations, Lipid Profiles and Hemodynamic Parameters in Patients with Type-2-Diabetes and Hemiplegia Related to Ischemic Stroke: A Pilot Study.International journal of environmental research and public health · 2021Article
- Predicting short- and long-term glycated haemoglobin response after insulin initiation in patients with type 2 diabetes mellitus using machine-learning algorithms.Diabetes, obesity & metabolism · 2019Observational
- Constructing treatment decision rules based on scalar and functional predictors when moderators of treatment effect are unknown.Journal of the Royal Statistical Society. Series C, Applied statistics · 2018Article
- Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017Article
- LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ.Diabetology & metabolic syndrome · 2016 · on this mapArticle
- Basal insulin combined incretin mimetic therapy with glucagon-like protein 1 receptor agonists as an upcoming option in the treatment of type 2 diabetes: a practical guide to decision making.Therapeutic advances in endocrinology and metabolism · 2014Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment response in patients with type 2 diabetes mellitus (T2DM) varies because of different genotypic and phenotypic characteristics. Results of clinical trials are based largely on aggregated estimates of treatment effect rather than individualized outcomes. This research assessed heterogeneity and differential treatment response using the subgroup identification based on differential effect search (SIDES) algorithm with data from a large multinational study.
methodsThis was a retrospective analysis of the DURABLE trial, a randomized, open-label, two-arm, parallel study. The trial enrolled 2091 insulin-naïve T2DM patients aged 30 to 80 years. Patients received twice-daily insulin lispro mix 75/25 (LM75/25) or once-daily insulin glargine (insulin glargine). The SIDES methodology was used to find subgroups where the treatment effect was substantially different from what was observed in the full population of the clinical trial. A subgroup identification tool implementing the SIDES algorithm was used to examine data for 1092 patients (584 LM75/25 and 508 insulin glargine), achieving at-goal 12- or 24-week glycated hemoglobin A1c (A1C) (≤7.0%).
resultsThe overall at-goal population treatment difference (A1C reduction) was not clinically meaningful, but a clinically meaningful difference was observed (A1C reduction 2.31% ± 0.06% LM75/25 versus 2.01% ± 0.07% insulin glargine; p = .001) in patients with a baseline fasting insulin level >11.4 μIU/ml and age ≤56 years.
conclusionThe observation that younger patients with higher levels of fasting insulin may benefit from a regimen that includes short-acting insulin targeting postprandial glycemia helps explain the heterogeneity in response and warrants further investigation.
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