To view enhanced content for this article go to http://www.medengine.com/Redeem/30A8F060401F68C0.
Identification of subgroups of patients that may benefit most from certain treatment is important because individual treatment response varies due to multiple contributing factors. The present study used the subgroup identification based on the differential effect search (SIDES) algorithm to identify subgroups with different treatment responses to insulin intensification therapies.
This was a post hoc analysis of a 24-week, multicenter, open-label, randomized, parallel study comparing prandial premixed therapy (PPT) to basal-bolus therapy (BBT). Patients with type 2 diabetes mellitus were randomized to PPT (insulin lispro mix 50/50 thrice daily with meals) or BBT (glargine at bedtime plus mealtime insulin lispro) insulin intensification therapies. The SIDES algorithm was used to identify the subgroups from at-goal patients [glycated hemoglobin (HbA1c) <7.0% (53.0 mmol/mol) at the end of 24 weeks; n = 182] who could have benefitted from insulin intensification therapies.
Baseline characteristics of overall at-goal patients were comparable between PPT and BBT groups. The SIDES algorithm identified patients with race other than Caucasian (i.e., African–American, Asian, and Hispanic) and baseline fasting blood glucose (FBG) <8.89 mmol/L as a subgroup that could respond better to PPT relative to BBT than the overall at-goal patient population. In this identified subgroup population, the HbA1c mean (standard deviation) changes from baseline to endpoint in PPT and BBT groups were −2.27 (0.88)% versus −2.05 (0.75)%; p = 0.40, respectively; while in the overall at-goal patients, the HbA1c changes were −2.17 (0.79)% versus −2.34 (1.00)%; p = 0.19, respectively.
The preliminary results showed that the subgroup of patients with race other than Caucasian and FBG <8.89 mmol/L may respond better to premixed intensification therapy. This result provides some preliminary information for further investigation in prospective studies.
Eli Lilly and Company.
Clinicaltrials.gov ID number: NCT00110370.
International Diabetes Federation. IDF diabetes atlas, 7th edn. Brussels (Belgium): International Diabetes Federation, 2013. http://www.idf.org/diabetesatlas. Accessed 24 Feb 2015.
American Diabetes Association. Pharmacologic approaches to glycemic treatment. Diabetes Care. 2017;40(Suppl 1):S64–74. CrossRef
Lipkovich I, Dmitrienko A, Denne J, Enas G. Subgroup identification based on differential effect search—a recursive partitioning method for establishing response to treatment in patient subpopulations. Stat Med. 2011;30:2601–21. PubMed
Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008;31:20–5. CrossRefPubMed
The Criteria Committee of the New York Heart Association. Functional capacity and objective assessment. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, MA: Little Brown; 1994.
Mori E, Ikeda M, Nakagawa M, Miyagishi H, Kosaka K. Pretreatment cognitive profile likely to benefit from donepezil treatment in dementia with Lewy bodies: pooled analyses of two randomized controlled trials. Dement Geriatr Cogn Disord. 2016;41:58–68. CrossRef
Patel S, Hee SW, Mistry D, et al. Identifying back pain subgroups: developing and applying approaches using individual patient data collected with clinical trials. Southampton (UK): NIHR Journals Library; 2016 Jul. Programme Grants for Applied Research, No. 4.10.
Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364–79. CrossRefPubMedPubMedCentral
Jia W, Xiao X, Ji Q, et al. Comparison of thrice-daily premixed insulin (insulin lispro premix) with basal-bolus (insulin glargine once-daily plus thrice-daily prandial insulin lispro) therapy in East Asian patients with type 2 diabetes insufficiently controlled with twice-daily premixed insulin: an open-label, randomised, controlled trial. Lancet Diabetes Endocrinol. 2015;3:254–62. CrossRefPubMed
Cerf ME. Beta cell dysfunction and insulin resistance. Front Endocrinol (Lausanne). 2013;4:37.
Sheu WH, Ji L, Lee WJ, Jabbar A, Han JH, Lew T. Efficacy and safety of premixed insulin analogs in Asian patients with type 2 diabetes: a systematic review. J Diabetes Investig. 2016. doi: 10.1111/jdi.12605.
American Diabetes Association. Standards of medical care in diabetes–2013. Diabetes Care. 2013;36(Suppl 1):S11–66. CrossRef
- Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens
Li Xin Shi
Peng Fei Li
Jia Ning Hou
- Springer Healthcare
Neu im Fachgebiet Innere Medizin
Meistgelesene Bücher aus der Inneren Medizin
Mail Icon II