A comparison of biphasic insulin aspart and insulin glargine administered with oral antidiabetic drugs in type 2 diabetes mellitus - A systematic review and meta-analysis

International Journal of Clinical Practice

Volumn 68, Issue 3, 2014, Pages 304-313

  Rys, P ^a   Wojciechowski, P ^a   Siejka, S ^a   Malecki P ^b   Hak, Ł ^b   Malecki, M T ^c,d  

^a HTA CONSULTING   (Poland)

^b Novo Nordisk Pharma Ltd   (Poland)

^c JAGIELLONIAN UNIVERSITY   (Poland)

^d UNIVERSITY HOSPITAL IN KRAKOW   (Poland)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN ASPART; INSULIN GLARGINE; ORAL ANTIDIABETIC AGENT; ANTIDIABETIC AGENT; BIPHASIC INSULIN; GLARGINE; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; INSULIN ASPART, INSULIN ASPART PROTAMINE DRUG COMBINATION 30:70; ISOPHANE INSULIN; LONG ACTING INSULIN;

BODY WEIGHT DISORDER; COMPARATIVE EFFECTIVENESS; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FOLLOW UP; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN TREATMENT; META ANALYSIS; NOCTURNAL HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW; WEIGHT GAIN; BLOOD; CHEMICALLY INDUCED; COMPARATIVE STUDY; DIABETES MELLITUS, TYPE 2; DIET RESTRICTION; DRUG COMBINATION; DRUG EFFECTS; FEMALE; MALE; METABOLISM; MIDDLE AGED; ORAL DRUG ADMINISTRATION; POSTPRANDIAL STATE; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; BIPHASIC INSULINS; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; FASTING; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN ASPART; INSULIN, ISOPHANE; INSULIN, LONG-ACTING; MALE; MIDDLE AGED; POSTPRANDIAL PERIOD; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME; WEIGHT GAIN;

EID: 84896712762     PISSN: 13685031     EISSN: 17421241     Source Type: Journal    
DOI: 10.1111/ijcp.12337     Document Type: Review

References (46)

1. American Diabetes Association. Standards of medical care in diabetes-2011. Diabetes Care 2011; 34 (Suppl. 1): S11-61.
2. Patel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008; 358: 2560-72.
3. Reichard P, Nilsson BY, Rosenqvist U,. The effect of long-term intensified insulin treatment on the development of microvascular complications of diabetes mellitus. N Engl J Med 1993; 329: 304-9.
4. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193-203.
5. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837-53.
6. Ray KK, Seshasai SRK, 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. The Lancet 2009; 373: 1765-72.
7. Rodbard HW, Blonde L, Braithwaite SS, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract 2007; 13 (Suppl. 1): 1-68.
8. Hirsch IB,. Insulin analogues. N Engl J Med 2005; 352: 174-83.
9. Valla V,. Therapeutics of diabetes mellitus: focus on insulin analogues and insulin pumps. Exp Diabetes Res 2010; 2010: 178372.
10. Raja-Khan N, Warehime SS, Gabbay RA,. Review of biphasic insulin aspart in the treatment of type 1 and 2 diabetes. Vasc Health Risk Manag 2007; 3: 919-35.
11. Monnier L, Lapinski H, Colette C,. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care 2003; 26: 881-5.
12. Boehm BO, Vaz JA, Brøndsted L, Home PD,. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. Eur J Intern Med 2004; 15: 496-502.
13. Garber AJ, Ligthelm R, Christiansen JS, Liebl A,. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab 2007; 9: 630-9.
14. Lasserson DS, Glasziou P, Perera R, Holman RR, Farmer AJ,. Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses. Diabetologia 2009; 52: 1990-2000.
15. Giugliano D, Maiorino MI, Bellastella G, Chiodini P, Ceriello A, Esposito K,. Efficacy of insulin analogs in achieving the hemoglobin A1c target of <7% in type 2 diabetes: meta-analysis of randomized controlled trials. Diabetes Care 2011; 34: 510-7.
16. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996; 17: 1-12.
17. Higgins JPT, Green S,. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011) [Internet]. The Cochrane Collaboration, 2011. www.cochrane-handbook.org (accessed 10 January 2013).
18. Tamemoto H, Ikoma A, Saitoh T, Ishikawa S-E, Kawakami M,. Comparison of once-daily glargine plus sulfonylurea with twice-daily 70/30 aspart premix in insulin-naive Japanese patients with diabetes. Diabetes Technol Ther 2007; 9: 246-53.
19. Kann PH, Wascher T, Zackova V, et al. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes 2006; 114: 527-32.
20. 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.
21. Strojek K, Bebakar WMW, Khutsoane DT, et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin 2009; 25: 2887-94.
22. Yang W, Jinnouchi H,. BIAsp 30 once daily is well tolerated and non-inferior to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes. Diabates 2012; 61 (Suppl. 1): A622.
23. Ligthelm RJ, Gylvin T, DeLuzio T, Raskin P,. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract 2011; 17: 41-50.
24. Yokoyama H, Tada J, Kamikawa F, Kanno S, Yokota Y, Kuramitsu M,. Efficacy of conversion from bedtime NPH insulin to morning insulin glargine in type 2 diabetic patients on basal-prandial insulin therapy. Diabetes Res Clin Pract 2006; 73: 35-40.
25. Statens Serum Institut-Statistikker [Internet]. http://medstat.dk/ (accessed 25 April 2013).
26. Norwegian Prescription Database [Internet]. http://www.norpd.no/ (accessed 25 April 2013).
27. Statistikdatabaser-Läkemedelsstatistik-Val [Internet]. http://192.137.163.49/sdb/lak/val.aspx (accessed 25 April 2013).
28. GIPdatabank [Internet]. http://www.gipdatabank.nl/ (accessed 25 April 2013).
29. Khutsoane D, Sharma SK, Almustafa M, et al. 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: 212-22.
30. Valensi P, Benroubi M, Borzi V, et al. 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.
31. Rhoads GG, Dain M-P, Zhang Q, Kennedy L,. Two-year glycaemic control and healthcare expenditures following initiation of insulin glargine vs. NPH insulin in type 2 diabetes. Diabetes Obes Metab 2011; 13: 711-7.
32. Temelkova-Kurktschiev TS, Koehler C, Henkel E, Leonhardt W, Fuecker K, Hanefeld M,. Postchallenge plasma glucose and glycemic spikes are more strongly associated with atherosclerosis than fasting glucose or HbA1c level. Diabetes Care 2000; 23: 1830-4.
33. Valentine WJ, Palmer AJ, Lammert M, Nicklasson L, Foos V, Roze S,. Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naïve type 2 diabetes patients: cost-effectiveness analysis in the UK setting. Curr Med Res Opin 2005; 21: 2063-71.
34. U.K. Prospective Diabetes Study Group. U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. Diabetes 1995; 44: 1249-58.
35. DCCT Research Group. 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.
36. Berntorp K, Haglund M, Larsen S, Petruckevitch A, Landin-Olsson M,. Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden. Prim Care Diabetes 2011; 5: 89-94.
37. Wolnik B, Hak L,. Multicenter, open-label, non-randomized, non-interventional observational study of safety of treatment initiation with a biphasic insulin aspart. Expert Opin Drug Saf 2013; 12: 137-44.
38. Herman WH, Buse JB, Arakaki RF, et al. Concomitant oral antihyperglycemic agent use and associated treatment outcomes after initiation of insulin therapy. Endocr Pract 2011; 17: 563-7.
39. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia 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). Diabetologia 2012; 55: 1577-96.
40. International Diabetes Federation. Clinical Guidelines Task Force. Global guideline for type 2 diabetes [Internet], 2012. http://www.idf.org/sites/ default/files/IDF%20T2DM%20Guideline.pdf (accessed 25 January 2013).
41. Global IDF/ISPAD guideline for diabetes in childhood and adolescence [Internet], 2011. http://www.ispad.org/sites/default/files/resources/files/idf- ispad-diabetes-in-childhood-and-adolescence-guidelines-2011-0.pdf (accessed 25 January 2013).
42. National Collaborating Centre for Chronic Conditions. Type 2 diabetes: national clinical guideline for management in primary and secondary care (update) [Internet]. London: Royal College of Physicians, 2008. http://www.nice.org.uk/nicemedia/live/11983/40803/40803.pdf (accessed 25 January 2013).
43. Holman RR, Farmer AJ, Davies MJ, et al.; 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med 2009; 361: 1736-47.
44. Owen V, Seetho I, Idris I,. Predictors of responders to insulin therapy at 1 year among adults with type 2 diabetes. Diabetes Obes Metab 2010; 12: 865-70.
45. Mäkimattila S, Nikkilä K, Yki-Järvinen H,. Causes of weight gain during insulin therapy with and without metformin in patients with type II diabetes mellitus. Diabetologia 1999; 42: 406-12.
46. Lee A, Morley JE,. Metformin decreases food consumption and induces weight loss in subjects with obesity with type II non-insulin-dependent diabetes. Obes Res 1998; 6: 47-53.