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      Effects of switching from prandial premixed insulin therapy to basal plus two times bolus insulin therapy on glycemic control and quality of life in patients with type 2 diabetes mellitus

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          Abstract

          Background

          The effects of switching from prandial premixed insulin therapy (PPT) injected three times a day to basal plus two times bolus insulin therapy (B2B) on glycemic control and quality of life were investigated in patients with type 2 diabetes mellitus.

          Methods

          The clinical course was prospectively observed during the first 16 weeks after switching to B2B (insulin glargine plus insulin glulisine before breakfast and dinner) in 27 subjects previously treated with PPT using 50/50 premixed insulin. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) was administered at the start and end of the study.

          Results

          The glycated hemoglobin (HbA 1c) level (8.3%±1.8% to 8.2%±1.1%) and the DTSQ score did not change between the start and end of the study. An improvement in HbA 1c level was found in nine (33%) subjects. The change in HbA 1c showed a significant negative correlation with baseline HbA 1c, and was significantly better in patients with a baseline HbA 1c >8.0% than in those with an HbA 1c ≤8.0% (−0.9±2.0 versus 0.3±0.6, respectively, P=0.02). The change in DTSQ score representing treatment satisfaction was significantly greater in patients whose HbA 1c level was improved than in those in whom it was not (2.7±3.6 versus −0.8±3.5, P=0.04).

          Conclusion

          B2B was noninferior to PPT with regard to HbA 1c levels in patients with type 2 diabetes mellitus. B2B should be considered particularly for subjects whose glycemic control is poor despite PPT.

          Most cited references16

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          Real-world factors affecting adherence to insulin therapy in patients with Type 1 or Type 2 diabetes mellitus: a systematic review.

          To identify real-world factors affecting adherence to insulin therapy in patients with Type 1 or Type 2 diabetes mellitus. A literature search was conducted in PubMed and EMBASE in November 2011 to identify studies reporting factors associated with adherence/non-adherence to insulin therapy in adults with Type 1 or Type 2 diabetes. Seventeen studies were identified; six used self-reported measures and 11 used calculated measures of adherence. Most (13/17) were conducted exclusively in the USA. Four categories of factors associated with non-adherence were identified: predictive factors for non-adherence, patient-perceived barriers to adherence, type of delivery device and cost of medication. For predictive factors and patient-perceived barriers, only age, female sex and travelling were associated with non-adherence in more than one study. Fear of injections and embarrassment of injecting in public were also cited as reasons for non-adherence. Conversely, adherence was improved by initiating therapy with, or switching to, a pen device (in four studies), and by changing to an insurance scheme that lowered the financial burden on patients (in two studies). Adherence to insulin therapy is generally poor. Few factors or patient-perceived barriers were consistently identified as predictive for non-adherence, although findings collectively suggest that a more flexible regimen may improve adherence. Switching to a pen device and reducing patient co-payments appear to improve adherence. Further real-world studies are warranted, especially in countries other than the USA, to identify factors associated with non-adherence and enable development of strategies to improve adherence to insulin therapy. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.
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            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.

            The purpose of this study was to compare two analog insulin therapies (prandial premixed therapy [PPT] versus basal/bolus therapy [BBT]) in type 2 diabetic patients previously treated with insulin glargine (>or=30 units/day) plus oral agents, with the aim of demonstrating noninferiority of PPT to BBT. Patients were randomly assigned to PPT (lispro mix 50/50: 50% insulin lispro protamine suspension and 50% lispro; n = 187) t.i.d. with meals or BBT (glargine at bedtime plus mealtime lispro; n = 187) in a 24-week, multicenter, open-label, noninferiority trial. Investigators could replace lispro mix 50/50 with lispro mix 75/25 at the evening meal if the fasting plasma glucose target was unachievable. Baseline A1C was similar (PPT 8.8%; BBT 8.9%; P = 0.598). At week 24, A1C was lower with BBT (6.78 vs. 6.95%, P = 0.021). A1C was reduced significantly from baseline for both therapies (P < 0.0001). The difference in A1C change from baseline to the end point (BBT minus PPT) was -0.22% (90% CI -0.38 to -0.07). Noninferiority of PPT to BBT was not demonstrated based on the prespecified noninferiority margin of 0.3%. The percentages of patients achieving target A1C <7.0% (PPT versus BBT, respectively) were 54 vs. 69% (P = 0.009) and for target
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              Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study).

              This observational study in patients with type 2 diabetes failing oral agent therapy with or without basal insulin was conducted to assess whether addition and self-titration of biphasic insulin aspart 70/30 (BIAsp 30) could achieve American Association of Clinical Endocrinologists (AACE)/International Diabetes Federation (IDF) and American Diabetes Association (ADA) glycemic targets (HbA(1c) or =7.5 and or =18 years of age, had diabetes > or =12 months and had received a stable antidiabetic regimen for at least 3 months [minimum of two oral antidiabetic drugs (OADs) or at least one OAD plus once-daily basal insulin < or =60 U]. Patients discontinued prior basal insulin and added one injection of BIAsp 30 (12 U or 70-100% of prior basal insulin dose within 15 min of dinner initiation). Patients self-titrated their BIAsp 30 dose with investigator guidance every 3 or 4 days to achieve pre-breakfast fasting blood glucose (FBG) of 80-110 mg/dl. At 16 weeks, a pre-breakfast injection of 6 U of BIAsp 30 was added if week 15 HbA(1c) exceeded 6.5%; the added dose was titrated to achieve pre-dinner BG of 80-110 mg/dl. After an additional 16 weeks, 3 U of pre-lunch BIAsp 30 was added if HbA(1c) exceeded 6.5%. This added dose was adjusted based on 2-h post-lunch BG to achieve postprandial glucose of 100-140 mg/dl. Subjects achieving an HbA(1c)< or =6.5% at 15 and 31 weeks completed the study at weeks 16 and 32 respectively. Addition of once-daily BIAsp 30 before dinner enabled 21% of the patients to achieve AACE and IDF targets (HbA(1c)< or =6.5%) and 41% to achieve ADA targets (HbA(1c) <7%). With two daily injections of BIAsp 30, these glycaemic goals were achieved by 52 and 70% of subjects. With three daily BIAsp 30 injections, 60% of patients achieved HbA(1c)< or =6.5%, and 77% achieved HbA(1c) <7.0%. This clinical trial demonstrates that initiation of once-daily BIAsp 30 to type 2 diabetes patients poorly controlled on various OAD regimens was an effective treatment approach for achieving glycaemic goals. Additional patients safely achieved these goals by increasing the number of BIAsp 30 injections from one to two, and then, if uncontrolled, from two to three doses per day. Eventually, most patients previously uncontrolled on OADs with or without basal insulin were controlled by the addition and vigorous titration of BIAsp 30 to oral agent therapy.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2014
                23 April 2014
                : 8
                : 391-396
                Affiliations
                Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, Tokyo, Japan
                Author notes
                Correspondence: Hiroyuki Ito, Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital, 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan, Tel +81 3 3673 1221, Fax +81 3 3673 1229, Email ito@ 123456edogawa.or.jp
                Article
                dddt-8-391
                10.2147/DDDT.S62709
                4003145
                24790413
                005bcf9e-8bb2-4c96-a7aa-c2d03a2d3650
                © 2014 Ito et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                History
                Categories
                Original Research

                Pharmacology & Pharmaceutical medicine
                type 2 diabetes mellitus,insulin therapy,basal plus two times bolus insulin therapy,prandial premixed insulin therapy,diabetes treatment satisfaction questionnaire

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