Treatment regimens with insulin analogues and haemoglobin A1c target of <7% in type 2 diabetes: A systematic review

Diabetes Research and Clinical Practice

Volumn 92, Issue 1, 2011, Pages 1-10

  Giugliano, Dario ^a   Maiorino, Maria Ida ^a   Bellastella, Giusppe ^a   Chiodini, Paolo ^a   Esposito, Katherine ^a  

^a SECOND UNIVERSITY OF NAPLES   (Italy)

Author keywords

Haemoglobin A1c target of <7 ; Insulin analogues; Insulin regimens; Type 2 diabetes

Indexed keywords

BIPHASIC INSULIN; GLIMEPIRIDE; GLITAZONE DERIVATIVE; HEMOGLOBIN A1C; INSULIN; INSULIN ASPART; INSULIN DERIVATIVE; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; METFORMIN; ORAL ANTIDIABETIC AGENT; PIOGLITAZONE; SULFONYLUREA;

CINAHL; COCHRANE LIBRARY; DIABETIC PATIENT; DRUG EFFICACY; DRUG RESPONSE; EMBASE; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; INSULIN HYPOGLYCEMIA; INSULIN TREATMENT; MEDLINE; META ANALYSIS; MULTIPLE DRUG DOSE; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; SYSTEMATIC REVIEW; TREATMENT DURATION; WEIGHT GAIN;

DIABETES MELLITUS, TYPE 2; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN;

EID: 79954583330     PISSN: 01688227     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.diabres.2010.08.006     Document Type: Review

References (69)

1. Skyler J.S., Bergenstal R., Bonow R.O., Buse J., Deedwania P., Gale E.A., et al. Intensive glycaemic control and the prevention of cardiovascular events: implications of the ACCORD, ADVANCE, and VA Diabetes trials: a position statement of the American Diabetes Association and a scientific statement of the American College of Cardiology Foundation and the American Heart Association. Diabetes Care 2009, 32:187-192.
2. Nathan D.M., Buse J., Davidson M.B., Ferrannini E., Holman R.R., Sherwin R., et al. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009, 32:193-203.
3. Centers for Disease Control and Prevention National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2005 2005, Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta.
4. Karter A.J., Subramanian U., Saha C., Crosson J.C., Parker M.M., Swain B.E., et al. Barriers to insulin initiation: the translating research into action for diabetes insulin starts project. Diabetes Care 2010, 33:733-735.
5. Hirsch I.B. Insulin analogues. N Engl J Med 2005, 352:174-183.
6. Hauber A., Gale E.A.M. The market in diabetes. Diabetologia 2006, 49:247-252.
7. Wild S., Roglic G., Green A., Sicree R., King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004, 27:1047-1053.
8. Lloyd-Jones D., Adams R., Carnethon M., De Simone G., Ferguson T.B., Flegal K., et al. Heart disease and stroke statistics-2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2009, 119:e21-e181.
9. Qayyum R., Bolen S., Maruthur N., Feldman L., Wilson L.M., Marinopoulos S.S., et al. Systematic review: comparative effectiveness and safety of premixed insulin analogues in type 2 diabetes. Ann Intern Med 2008, 149:549-559.
10. Lasserson D.S., Glasziou P., Perera R., Holman R.R., Farmer A.J. Optimal insulin regimens in type 2 diabetes mellitus: systemic review and meta-analysis. Diabetologia 2009, 52:1990-2000.
11. Singh S.R., Ahmad F., Lal A., Yu C., Bai Z., Bennett H. Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis. CMAJ 2009, 180:385-397.
12. Bazzano L.A., Lee L.J., Shi L., Reynolds K., Jackson J.A., Fonseca V., et al. Safety and efficacy of glargine compared with NPH insulin for the treatment of type 2 diabetes: a meta-analysis of randomized controlled trials. Diabetic Med 2008, 25:924-932.
13. Liberati A., Altman D.G., Tetzlaff J., Mulrow C., Gøtzsche P.C., Ioannidis J.P., et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med 2009, 151:W-65-W-94.
14. American Diabetes Association Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care 1997, 20:1183-1197.
15. Jadad A.R., Moore R.A., Carroll D., Jenkinson C., Reynolds D.J., Gavaghan D.J., et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996, 17:1-12.
16. Stuart A., Ord J.K. Kendall's advanced theory of statistics 1994, Edward Arnold, London. 6th ed.
17. DerSimonian R., Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986, 7:177-188.
18. Higgings J.P.T., Thompson S.G. Quantifying heterogeneity in a meta-analysis. Stat Med 2002, 21:1539-1558.
19. Bastyr III E.J., Stuart C.A., Brodows R.G., Schwartz S., Graf C.J., Zagaret A., et al. Therapy focused on lowering postprandial glucose, not fasting glucose, may be superior for lowering HbA1c. Diabetes Care 2000, 23:1236-1241.
20. Riddle M.C., 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, 26:3080-3086. Insulin Glargine 4002 Study Investigators.
21. Malone J.K., Beattie S.D., Campaigne B.N., Johnson P.A., Howard A.S., Milicevic Z. Therapy after single oral agent failure: adding a second oral agent or an insulin mixture?. Diabetes Res Clin Pract 2003, 62:187-195.
22. Malone J.K., Kerr L.F., Campaigne B.N., Sachson R.A., Holcombe J.H. 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, 26:2034-2044. Lispro Mixture-Glargine Study Group.
23. Heine R.J., Van Gaal L.F., Johns D., Mihm M.J., Widel M.H., Brodows R.G., et al. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Int Med 2005, 143:559-569.
24. Janka H.U., Plewe G., Riddle M.C., Kliebe-Frisch C., Schweitzer M.A., Yki-Järvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 2005, 28:254-259.
25. Raskin P., Allen E., Hollander P., Lewin A., Gabbay R.A., Hu P., et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 2005, 28:260-265.
26. Malone J.K., Bai S., Campaigne B.N., Reviriego J., Augendre-Ferrante B. Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with type 2 diabetes. Diabetic Med 2005, 22:374-381.
27. Davies M., Storms F., Shutler S., Bianchi-Biscay M., Gomis R. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes. Comparison of two treatment algorithms using insulin glargine. Diabetes Care 2005, 28:1282-1288. For the Atlantus Study Group.
28. Kann P.H., Wascher T., Zackova V., Moeller J., Medding J., Szocs A. 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, 114:527-532.
29. Jacober S.J., Scism-Bacon J.L., Zagar A.J. A comparison of intensive mixture therapy with basal insulin therapy in insulin-naïve patients with type 2 diabetes receiving oral antidiabetes agents. Diabetes Obes Metab 2006, 448-455.
30. Kazda C., Hülstrunk H., Helsberg K., Langer F., Forst T., Hanefeld M. Prandial insulin substitution with insulin lispro or insulin lispro mid mixture vs. basal therapy with insulin glargine: a randomized controlled trial in patients with type 2 diabetes beginning insulin therapy. J Diabetes Complicat 2006, 20:145-152.
31. Kennedy L., Herman W.H., Strange P., Harris A. Impact of active versus usual algorithmic titration of basal insulin and point-of-care versus laboratory measurement of HbA1c on glycemic control in patients with type 2 diabetes: the glycemic optimization with algorithms and labs at point of care (GOAL A1C) trial. Diabetes Care 2006, 29:1-8. GOAL AIC Team.
32. Hermansen K., Davies M., Derezinski T., Martinez Ravn G., Clauson P., Home P. 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-naive people with type 2 diabetes. Diabetes Care 2006, 29:1269-1274.
33. Rosenstock J., Sugimoto D., Strange P., Stewart J.A., Soltes-Rak E., Dailey G. Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naive patients. Diabetes Care 2006, 29:554-559.
34. Gerstein H.C., Yale J.F., Harris S.B., Issa M., Stewart J.A., Dempsey E. A randomized trial of adding insulin glargine vs. avoidance of insulin in people with type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of metformin and/or sulphonylureas. The Canadian INSIGHT (implementing new strategies with insulin glargine for hyperglycaemia treatment) study. Diabetic Med 2006, 23:736-742.
35. Standl E., Maxeiner S., Raptis S. Once-daily insulin glargine administration in the morning compared to bedtime in combination with morning glimepiride in patients with type 2 diabetes: an assessment of treatment flexibility. Horm Metab Res 2006, 38:172-177. HOE901/4009 Study Group.
36. Holman R.R., Thorne K.I., Farmer A.J., Davies M.J., Keenan J.F., Paul S., et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007, 357:1716-1730.
37. Ushakova O., Sokolovskaya V., Morozova A., Valeeva F., Zanozina O., Sazonova O. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in Russia. Clin Ther 2007, 29:2374-2384.
38. Robbins D.C., Beisswenger P.J., Ceriello A., Goldberg R.B., Moses R.G., Pagkalos E.M., et al. Mealtime 50/50 basal+prandial insulin analogue mixture with a basal insulin analogue, both plus metformin, in the achievement of target HbA1c and pre- and post-prandial blood glucose levels in patients with type 2 diabetes: a multinational, 24-week, randomized, open-label, parallel-group comparison. Clin Ther 2007, 29:2349-2364.
39. Barnett A.H., Burger J., Johns D., Brodows R., Kendall D.M., Roberts A., et al. Tolerability and efficacy of exenatide and titrated insulin glargine in adult patients with type 2 diabetes previously uncontrolled with metformin or a sulfonylurea: a multinational, randomized, open-label, two-period, crossover noninferiority trial. Clin Ther 2007, 29:2333-2348.
40. Nauck M.A., Duran S., Kim D., Johns D., Northrup J., Festa A., et al. A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia 2007, 50:259-267.
41. Esposito K., Ciotola M., Maiorino M., Gualdiero R., Schisano B., Ceriello A., et al. Addition of neutral protamine lispro insulin or insulin glargine to oral type 2 diabetes regimens for patients with suboptimal glycemic control: a randomized trial. Ann Intern Med 2008, 149:531-539.
42. Bretzel R.G., Nuber U., Landgraf W., Owens D.R., Bradley C., Linn T. Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial. Lancet 2008, 371:1073-1084.
43. Hirao K., Arai K., Yamauchi M., Takagi H., Kobayashi M. Six-month multicentric, open-label, randomized trial of twice-daily injections of biphasic insulin aspart 30 versus multiple daily injections of insulin aspart in Japanese type 2 diabetic patients (JDDM 11). Diabetes Res Clin Pract 2008, 79:171-176. Japan Diabetes Clinical Data Management Study Group.
44. Hollander P., Cooper J., Bregnhøj J., Pedersen C.B. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther 2008, 30:1976-1987.
45. Rosenstock J., Davies M., Home P.D., Larsen J., Koenen C., Schernthaner G. 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, 51:408-416.
46. Rosenstock J., Ahmann A.J., 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, 31:20-25.
47. Lankisch M.R., Ferlinz K.C., Leahy J.L., Scherbaum W.A. Introducing a simplified approach to insulin therapy in type 2 diabetes: a comparison of two single-dose regimens of insulin glulisine plus insulin glargine and oral antidiabetic drugs. Diabetes Obes Metab 2008, 10:1178-1185. Orals Plus Apidra and LANTUS (OPAL) study group.
48. Yang W., Ji Q., Zhu D., Yang J., Chen L., Liu Z. Biphasic insulin aspart 30 three times daily is more effective than a twice-daily regimen, without increasing hypoglycemia, in Chinese subjects with type 2 diabetes inadequately controlled on oral antidiabetes drugs. Diabetes Care 2008, 31:852-856.
49. Bergenstal R.M., Johnson M., Powers M.A., Wynne A., Vlajnic A., Hollander P., et al. Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care 2008, 31:1305-1310.
50. Liebl A., Prager R., Binz K., Kaiser M., Bergenstal R., Gallwitz B., et al. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab 2009, 11:45-52.
51. Buse J.B., Wolffenbuttel B.H., Herman W.H., Shemonsky N.K., Jiang H.H., Fahrbach J.L., et al. Durability of basal versus lispro mix 75/25 insulin efficacy (durable) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care 2009, 32:1007-1013.
52. Raz I., Wilson P.W., Strojek K., Kowalska I., Bozikov V., Gitt A.K., et al. Effects of prandial versus fasting glycemia on cardiovascular outcomes in type 2 diabetes: the HEART2D trial. Diabetes Care 2009, 32:381-386.
53. Riddle M., Pencek R., Charenkavanich S., Lutz K., Wilhelm K., Porter L. Randomized comparison of pramlintide or mealtime insulin added to basal insulin treatment for patients with type 2 diabetes. Diabetes Care 2009, 32:1577-1582.
54. Russell-Jones D., Vaag A., Schmitz O., Sethi B.K., Lalic N., Antic S., et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia 2009, 52:2046-2055.
55. Kawamori R., Iwamoto Y., Kadowaki T., Iwasaki M., Kim S.W., Woo J.T., et al. Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab 2009, 11:900-909.
56. Blicklé J.F., Hancu N., Piletic M., Profozic V., Shestakova M., Dain M.P., et al. Insulin glargine provides greater improvements in glycaemic control vs. intensifying lifestyle management for people with type 2 diabetes treated with OADs and 7-8% A1c levels. The TULIP study. Diabetes Obes Metab 2009, 11:379-386.
57. Raskin P., Matfin G., Schwartz S.L., Chaykin L., Chu P.L., Braceras R., 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.
58. Blonde L., Merilainen M., Karwe V., Raskin P. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets--the TITRATE study. Diabetes Obes Metab 2009, 11:623-631. TITRATE Study Group.
59. Raskin P., Gylvin T., Weng W., Chaykin L. Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes. Diabetes Metab Res Rev 2009, 25:542-548.
60. Cucinotta D., Smirnova O., Christiansen J.S., Kanc K., le Devehat C., Wojciechowska M., et al. Three different premixed combinations of biphasic insulin aspart--comparison of the efficacy and safety in a randomized controlled clinical trial in subjects with type 2 diabetes. Diabetes Obes Metab 2009, 11:700-708.
61. Rosenstock J., Eliaschewitz F.G., Heilmann C.R., Muchmore D.B., Hayes R.P., Belin R.M. Comparison of prandial AIR inhaled insulin alone to intensified insulin glargine alone and to AIR insulin plus intensified insulin glargine in patients with type 2 diabetes previously treated with once-daily insulin glargine. Diabetes Technol Ther 2009, 11(Suppl. 2):S63-S73.
62. Gross J.L., Nakano M., Colon-Vega G., Ortiz-Carasquillo R., Ferguson J.A., Althouse S., et al. Initiation of prandial insulin therapy with AIR inhaled insulin or insulin lispro in patients with type 2 diabetes: a randomized noninferiority trial. Diabetes Technol Ther 2009, 11(Suppl. 2):S27-S34.
63. Oyer D.S., Shepherd M.D., Coulter F.C., Bhargava A., Brett J., Chu P.L., et al. A(1c) control in a primary care setting: self-titrating an insulin analog pre-mix (INITIATE plus trial). Am J Med 2009, 122:1043-1049.
64. Strojek K., Bebakar W.M., Khutsoane D.T., Pesic M., Smahelová A., Thomsen H.F., 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, 25:2887-2894.
65. Fritsche A., Larbig M., Owens D., Häring H.-U. Comparison between a basal-bolus and a premixed insulin regimen in individuals with type 2 diabetes--results of the GINGER study. Diabetes Obes Metab 2010, 12:115-123. On behalf of the GINGER study group.
66. Fogelfeld L., Dharmalingam M., Robling K., Jones C., Swanson D., Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naïve patients with type 2 diabetes. Diabetic Med 2010, 27:181-188.
67. Gale E.A.M, Beattie S.D., Hu J., Koivisto V., Tan M.H. Recruitment to a clinical trial improves glycemic control in patients with diabetes. Diabetes Care 2007, 30:2989-2992.
68. Holman R.R., Farmer A.J., Davies M.J., Levy J.C., Darbyshire J.L., Keenan J.F., et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med 2009, 361:1736-1747.
69. 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, 26:881-885.