Insulin analogues: how observational studies provide key insights into management of patients with type 2 diabetes mellitus

References

• Wild S, Roglic G, Sicree R, et al. Global prevelance of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27:1047-53
   PubMed Web of Science ®Google Scholar
• Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:837-53
   Google Scholar
• Stratton M, Adler AI, Neil H, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35); prospective observations study. BMJ 2000;321:405-12
   PubMed Web of Science ®Google Scholar
• The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329:977-86
   PubMed Web of Science ®Google Scholar
• Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. N Eng J Med 2005;353:2643-53
   PubMed Web of Science ®Google Scholar
• Wright A, Burden AC, Paisey RB, et al. U.K. Prospective Diabetes Study Group. Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57). Diabetes Care 2002;25:330-36
   PubMed Web of Science ®Google Scholar
• Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577-89
   PubMed Web of Science ®Google Scholar
• Ray KK, Seshasai SR, Wijesuriya S, et al. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009;373:1765-72
   PubMed Web of Science ®Google Scholar
• Marso SP, Kennedy KF, House JA, et al. The effect of intensive glucose control on all-cause and cardiovascular mortality, myocardial infarction and stroke in persons with type 2 diabetes mellitus: a systematic review and meta-analysis. Diab Vasc Dis Res 2010;7:119-30
   PubMed Web of Science ®Google Scholar
• Rodbard HW, Jellinger PS, Davidson JA, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract 2009;15:540-59
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Standards of medical care in diabetes – 2011. Diabetes Care 2011;34:S11-S61
   PubMed Web of Science ®Google Scholar
• IDF Clinical Guidelines Task Force. Global Guideline for Type 2 Diabetes: recommendations for standard, comprehensive, and minimal care. Diabet Med 2006;23:579-93
   PubMed Web of Science ®Google Scholar
• Calvert MJ, McManus RJ, Freemantle N. Management of type 2 diabetes with multiple oral hypoglycaemic agents or insulin in primary care: retrospective cohort study. Br J Gen Pract 2007;57:455-60
   PubMed Web of Science ®Google Scholar
• Fox KM, Gerber Pharmd RA, et al. Prevalence of inadequate glycemic control among patients with type 2 diabetes in the United Kingdom general practice research database: a series of retrospective analyses of data from 1998 through 2002. Clin Ther 2006;28:388-95
   PubMed Web of Science ®Google Scholar
• Dale J, Martin S, Gadsby R. Insulin initiation in primary care for patients with type 2 diabetes: 3-year follow-up study. Prim Care Diabetes 2010;4:85-9
   PubMed Web of Science ®Google Scholar
• Preventive Services Task Force. Guide to clinical preventive services: report of the U.S. Preventive Services Task Force, 2nd edn. Baltimore: Williams & Wilkins, 1996
   Google Scholar
• Silverman SL. From randomized controlled trials to observational studies. Am J Med 2009;122:114-20
   PubMed Web of Science ®Google Scholar
• Tuma RS. Statisticians set sights on observational studies. J Natl Cancer Inst 2007;99:664-65,668
   PubMed Web of Science ®Google Scholar
• Mann CJ. Observational research methods. Research design II: cohort, cross sectional, and case–control studies. Emerg Med J 2003;20:54-60
   PubMed Web of Science ®Google Scholar
• Hoppe DJ, Schemitsch EH, Morshed S, et al. J Bone Joint Surg Am 2009;91(Suppl 3):2-9
   PubMedGoogle Scholar
• von Elm E, Egger M, Altman DG, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ 2007;335:806-8
   PubMed Web of Science ®Google Scholar
• von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Epidemiology 2007;18:800-4
   PubMed Web of Science ®Google Scholar
• Ligthelm RJ, Borzi V, Gumprecht J, et al. Importance of observational studies in clinical practice. Clin Ther 2007;29:1284-92
   Web of Science ®Google Scholar
• Ishii H, Anderson JH Jr, Yamamura A, et al. Improvement of glycemic control and quality-of-life by insulin lispro therapy: assessing benefits by ITR-QOL questionnaires. Diabetes Res Clin Pract 2008;81:169-78
   PubMed Web of Science ®Google Scholar
• Khutsoane D, Sharma SK, Almustafa M, et al. PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab 2008;10(3):212-22
   PubMed Web of Science ®Google Scholar
• Schreiber SA, Haak T. Insulin glargine benefits patients with type 2 diabetes inadequately controlled on oral antidiabetic treatment: an observational study of everyday practice in 12,216 patients. Diabetes Obes Metab 2006;9:31-8
   Web of Science ®Google Scholar
• Siegmund T, Weber S, Blankenfeld H, et al. Comparison of insulin glargine versus NPH insulin in people with Type 2 diabetes mellitus under outpatient-clinic conditions for 18 months using a basal-bolus regimen with a rapid-acting insulin analogue as mealtime insulin. Exp Clin Endocrinol Diabetes 2007;115:349-53
   PubMed Web of Science ®Google Scholar
• Valensi P, Benroubi M, Borzi V, et al. IMPROVE Study Group Expert Panel. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Int J Clin Pract 2009;63:522-31
   PubMed Web of Science ®Google Scholar
• Kanazawa Y, Igarashi Y, Komiya K, et al. Long-term efficacy of insulin glargine after switching from NPH insulin as intensive replacement of basal insulin in Japanese diabetes mellitus. Comparison of efficacy between type 1 and type 2 diabetes (JUN-LAN Study 1.2). Endocr J 2007;54:975-83
   PubMed Web of Science ®Google Scholar
• Hammer H, Klinge A. Patients with type 2 diabetes inadequately controlled on premixed insulin: effect of initiating insulin glargine plus oral antidiabetic agents on glycaemic control in daily practice. Int J Clin Pract 2007;61:2009-18
   PubMed Web of Science ®Google Scholar
• Yoshioka N, Kurihara Y, Manda N, et al. Step-up therapy with biphasic insulin aspart-70/30 – Sapporo 1-2-3 study. Diabetes Res Clin Pract 2009;85:47-52
   PubMed Web of Science ®Google Scholar
• Raskin P, Matfin G, Schwartz SL, et al. Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: the ACTION Study (Achieving Control Through Insulin plus Oral ageNts). Diabetes Obes Metab 2009;11:27-32
   PubMed Web of Science ®Google Scholar
• Krzymién J, Koblik T, Nazar M. Multicenter, open-label, nonrandomized, observational safety study I subjects using insulin aspart in basal-bolus regimen for the treatment of diabetes. Pol Arch Med Wewn 2010;120:444-51
   PubMed Web of Science ®Google Scholar
• Gumprecht J, Benroubi M, Borzi V, et al. Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE observational study. Int J Clin Pract 2009;63:966-72
   PubMed Web of Science ®Google Scholar
• Shah S, Benroubi M, Borzi V, et al. Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study. Int J Clin Pract 2009;63:574-82
   PubMed Web of Science ®Google Scholar
• Dornhorst A, Luddeke HJ, Koenen C, et al. Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal-only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14-week follow-up data from PREDICTIVE. Diabetes Obes Metab 2008;10:75-81
   PubMed Web of Science ®Google Scholar
• Dornhorst A, Lüddeke HJ, Sreenan S, et al. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort. Int J Clin Pract 2007;61:523-28
   PubMed Web of Science ®Google Scholar
• Hermansen K, Lund P, Clemmensen K, et al. 3-Month results from Denmark within the globally prospective and observational study to evaluate insulin detemir treatment in type 1 and type 2 diabetes: the PREDICTIVE study. Rev Diabet Stud 2007;4:89-97
   PubMedGoogle Scholar
• Jang HC, Guler S, Shestakova M; PRESENT Study Group. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. Int J Clin Pract 2008;62:1013-18
   PubMed Web of Science ®Google Scholar
• Gao Y, Guo XH, Vaz JA; PRESENT Study Group. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study. Diabetes Obes Metab 2009;11:33-40
   PubMed Web of Science ®Google Scholar
• Marre M, Pinget M, Gin H, et al. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain: 52-week data from the PREDICTIVE study in a cohort of French patients with type 1 or type 2 diabetes. Diabetes Metab 2009;35:469-75
   PubMed Web of Science ®Google Scholar
• Dornhorst A, Lüddeke HJ, Sreenan S, et al. Insulin detemir improves glycaemic control without weight gain in insulin-naïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract 2008;62:659-65
   PubMed Web of Science ®Google Scholar
• Gao Y, Guo XH. Switching from human insulin to biphasic insulin aspart 30 treatment gets more patients with type 2 diabetes to reach target glycosylated hemoglobin <7%: the results from the China cohort of the PRESENT study. Chin Med J (Engl) 2010;123:1107-11
   PubMed Web of Science ®Google Scholar
• Schreiber SA, Ferlinz K, Haak T. The long-term efficacy of insulin glargine plus oral antidiabetic agents in a 32-month observational study of everyday clinical practice. Diabetes Technol Ther 2008;10:121-7
   PubMed Web of Science ®Google Scholar
• Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003;26:3080-6
   PubMed Web of Science ®Google Scholar
• Hermansen K, Davies M, Derezinski T, et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin naïve people with type 2 diabetes. Diabetes Care 2006;29:1269-74
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Davies M, Home PD, et al. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia 2008;51:408-16
   PubMed Web of Science ®Google Scholar
• Yki-Jarvinen H, Kauppinen-Makelin R, Tiikkainen M, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006;49:442-51
   PubMed Web of Science ®Google Scholar
• Philis-Tsimikas A, Charpentier G, Clauson P, et al. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006;28:1569-81
   PubMed Web of Science ®Google Scholar
• Malone JK, Kerr LF, Campaigne BN, et al. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther 2004;26:2034-44
   PubMed Web of Science ®Google Scholar
• Raskin P, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 2005;28:260-5
   PubMed Web of Science ®Google Scholar
• Garber AJ, Wahlen J, Wahl T, et al. 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). Diabetes Obes Metab 2006;8:58-66
   PubMed Web of Science ®Google Scholar
• Heidenreich PA. Patient adherence: the next frontier in quality improvement. Am J Med 2004;117:130-2
   PubMed Web of Science ®Google Scholar
• Chatterjee JS. From compliance to concordance in diabetes. J Med Ethics 2006;32:507–51
   PubMed Web of Science ®Google Scholar
• Karter AJ, Subramanian U, Saha C, et al. Barriers to insulin initiation: the translating research into action for diabetes insulin starts project. Diabetes Care 2010;33:733-5
   PubMed Web of Science ®Google Scholar
• Meneghini L, Koenen C, Weng W, et al. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes – results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab 2007;9:902-13
   PubMed Web of Science ®Google Scholar