Impact of therapeutic advances on hypoglycaemia in type 2 diabetes

Diabetes/Metabolism Research and Reviews

Volumn 24, Issue 4, 2008, Pages 257-285

  Boyle, Patrick J ^a   Zrebiec, John ^b  

^a UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Hypoglycaemia; Insulin; Insulin analogues; Oral anti diabetic agents; Type 2 diabetes

Indexed keywords

2,4 THIAZOLIDINEDIONE; ALPHA GLUCOSIDASE INHIBITOR; CHLORPROPAMIDE; DIPEPTIDYL PEPTIDASE IV; GLIBENCLAMIDE; GLIBENCLAMIDE PLUS METFORMIN; GLICLAZIDE; GLIPIZIDE; GLUCAGON LIKE PEPTIDE 1; HEMOGLOBIN A1C; HUMAN INSULIN; INSULIN; INSULIN ASPART; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; INSULIN ZINC SUSPENSION; ISOPHANE INSULIN; METFORMIN; METFORMIN PLUS NATEGLINIDE; MIGLITOL; ORAL ANTIDIABETIC AGENT; PLACEBO; PRAMLINTIDE; REPAGLINIDE; ROSIGLITAZONE; SITAGLIPTIN; SULFONYLUREA; UNINDEXED DRUG;

ADJUVANT THERAPY; AGE DISTRIBUTION; ALCOHOL CONSUMPTION; BEDTIME DOSAGE; BEHAVIOR; BLOOD GLUCOSE MONITORING; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; DIET; DIET RESTRICTION; DISEASE SEVERITY; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; DRUG SUBSTITUTION; DRUG WITHDRAWAL; EXERCISE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN INFUSION; INSULIN PUMP; INSULIN RESISTANCE; INSULIN SENSITIVITY; LIFESTYLE; MONOTHERAPY; MORNING DOSAGE; MORTALITY; NEGRO; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS ISLET BETA CELL; PATHOPHYSIOLOGY; PATIENT EDUCATION; PRIORITY JOURNAL; REVIEW; RISK FACTOR; RISK REDUCTION; SELF MONITORING; SEX DIFFERENCE;

DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; PATIENT EDUCATION AS TOPIC;

EID: 44949255097     PISSN: 15207552     EISSN: 15207560     Source Type: Journal    
DOI: 10.1002/dmrr.795     Document Type: Review

References (219)

1. Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27: 1047-1053.
2. Honeycutt AA, Boyle JP, Broglio KR, et al. A dynamic Markov model for forecasting diabetes prevalence in the United States through 2050. Health Care Manag Sci 2003; 6: 155-164.
3. Davis T, Edelman SV. Insulin therapy in type 2 diabetes. Med Clin North Am 2004; 88: 865-895.
4. Amos AF, McCarty DJ, Zimmer P. The rising global burden of diabetes and its complications: estimates and projections to the year 2010. Diabet Med 1997; 14(Suppl. 5): S1-S85.
5. Centers for Disease Control. National diabetes fact sheet. United States, 2005: general information. http://wwwcdcgov/diabetes/pubs/pdf/ ndfs_2005pdf 2005; Centers for Disease Control 2005, 3-30-2007.
6. American Diabetes Association. Standards of medical care in diabetes-2006. Diabetes Care 2006; 29(Suppl. 1): S4-S42.
7. American Association of Clinical Endocrinologists. The American Association of Clinical Endocrinologists Medical Guidelines for the Management of Diabetes Mellitus: the AACE system of intensive diabetes self-management-2002 update. Endocr Pract 2002; 8 (Suppl. 1): 40-82.
8. International Diabetes Federation Clinical Guidelines Task Force. Global guideline for type 2 diabetes. International Diabetes Federation Clinical Guidelines Task Force. International Diabetes Federation: Brussels, 2005; 1-79.
9. Genuth S. Insights from the diabetes Control and Complications Trial/ Epidemiology of Diabetes Interventions and Complications Study on the Use of Intensive Glycaemic Treatment to Reduce the Risk of Complications of Type 1 Diabetes. Endocr Pract 2006; 12(Suppl. 1): 34-41.
10. Saaddine JB, Cadwell B, Gregg EB, et al. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988-2002. Ann Intern Med 2006; 144: 465-474.
11. Kahn SE, Haffner SM, Heise MA, et al. Glycaemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006; 355: 2427-2443.
12. Perlin JB, Pogach LM. Improving the outcomes of metabolic conditions: managing momentum to overcome clinical inertia. Ann Intern Med 2006; 144: 525-527.
13. Banarer S, Cryer PE. Hypoglycemia in type 2 diabetes. Med Clin North Am 2004; 88: 1107-1116.
14. Fritsche A, Haring H-U. Togel E, et al. Treat-to-target with add-on basal insulin-can insulin glargine reduce the barrier to target attainment? Diabetes 2003; 52(Suppl. 1): A119.
15. Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care 2005; 28: 2948-2961.
16. Braunstein SN, White JR. Trends in the management of type 2 diabetes: an emerging role for insulin. J Manag Care Pharm 2005; 11: S2-11.
17. Guerci B, Drouin P, Grange V, et al. Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. Diabetes Metab 2003; 29: 587-594.
18. Burge MR, Sood V, Sobhy TA, et al. Sulphonylurea-induced hypoglycaemia in type 2 diabetes mellitus: a review. Diabetes Obes Metab 1999; 1: 199-206.
19. Akram K, Pedersen-Bjergaard U, Borch-Johnsen K, et al. Frequency and risk factors of severe hypoglycemia in insulin-treated type 2 diabetes: a literature survey. J Diabetes Complicat 2006; 20: 402-408.
20. American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005; 28: 1245-1249.
21. UK Hypoglycaemia Study Group. Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia 2007; 50: 1140-1147.
22. United Kingdom 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: 837-853.
23. Wright AD, Cull CA, MacLeod KM, et al. Hypoglycemia in Type 2 diabetic patients randomized to and maintained on monotherapy with diet, sulfonylurea, metformin, or insulin for 6 years from diagnosis: UKPDS73. J Diabetes Complicat 2006; 20: 395-401.
24. DCCT Research Group. Hypoglycemia in the Diabetes control and complications trial. Diabetes 1997; 46: 271-286.
25. Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 1995; 28: 103-117.
26. Abraira C, Colwell JA, Nuttall FQ, et al. Veterans Affairs Cooperative Study on glycaemic control and complications in type II diabetes (VA CSDM). Diabetes Care 1995; 18: 1113-1123.
27. Saudek CD, Duckworth WC, Giobbie-Hurder A, et al. Implantable insulin pump vs multiple-dose insulin for non-insulin-dependent diabetes mellitus: a randomized clinical trial. Department of Veterans Affairs Implantable Insulin Pump Study Group. JAMA 1996; 276: 1322-1327.
28. Murata GH Duckworth WC, Hoffman RM, et al. Hypoglycemia in type 2 diabetes: a critical review. Biomed Pharmacother 2004; 58: 551-559.
29. Henderson JN, Allen KV, Deary IJ, et al. Hypoglycaemia in insulin-treated Type 2 diabetes: frequency, symptoms and impaired awareness. Diabet Med 2003; 20: 1016-1021.
30. Donnelly LA, Morris AD, Frier BM, et al. Frequency and predictors of hypoglycaemia in Type 1 and insulin-treated type 2 diabetes: a population-based study. Diabet Med 2005; 22: 749-755.
31. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care 2003; 26: 1902-1912.
32. Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of type I and type II diabetes. Diabetologia 2002; 45: 937-948.
33. Boyle PJ, Zrebiec J. Management of diabetes-related hypoglycemia. South Med J 2007; 100: 183-194.
34. Centers for Disease Control. Deaths among patients using continuous subcutaneous insulin infusion pumps-United States. MMWR Morb Mortal Wkly Rep 1982; 31: 80-82, 87.
35. Holstein A, Egberts EH. Risk of hypoglycaemia with oral antidiabetic agents in patients with Type 2 diabetes. Exp Clin Endocrinol Diabetes 2003; 111: 405-414.
36. Allen KV, Frier BM. Nocturnal hypoglycemia: clinical manifestations and therapeutic strategies toward prevention, Endocr Pract 2003; 9: 530-543.
37. Boyle PJ, Zrebiec J. Physiological and behavioral aspects of glycaemic control and hypoglycemia in diabetes. South Med J. 2007; 100: 175-182.
38. Davis RE, Morrissey M, Peters JR, et al. Impact of hypoglycaemia on quality of life and productivity in type 1 and type 2 diabetes. Curr Med Res Opin 2005; 21: 1477-1483.
39. van Staa T, Abenhaim L, Monette J. Rates di hypoglycemia in users of sulfonylureas. J Clin Epidemiol 1997; 50: 735-741.
40. Shorr RI, Ray WA, Daugherty JR, et al. Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med 1997; 157: 1681-1686.
41. Chelliah A, Burge MR. Hypoglycaemia in elderly patients with diabetes mellitus: causes and strategies for prevention. Drugs Aging 2004; 21: 511-530.
42. Ben-Ami H, Nagachandra P, Mendelson A, et al. Drug-induced hypoglycemic coma in 102 diabetic patients. Arch Intern Med 1999; 159: 281-284.
43. Phillips LS, Dunning BE. Nateglinide (Starlix®): update on a new antidiabetic agent. Int J Clin Pract 2003; 57: 535-541.
44. Hatorp V, Walther KH, Christensen MS, et al. Single-dose pharmacokinetics of repaglinide in subjects with chronic liver disease. J Clin Pharmacol 2000; 40: 142-152.
45. Cull CA, Wright AD, MacLeod EM, et al. Hypoglycaemia in patients with type 2 diabetes in the UKPDS. Diabetologia 2001; (Supplement 1)p: A217.
46. Heller SR, Macdonald IA, Tattersall RB. Counterregulation in type 2 (non-insulin-dependent) diabetes mellitus. Normal endocrine and glycaemic responses, up to ten years after diagnosis. Diabetologia 1987; 30: 924-929.
47. Gallwitz B. Glucagon-like peptide-1-based therapies for the treatment of type 2 diabetes mellitus. Treat Endocrinol 2005; 4: 361-370.
48. Flyvbjerg A. Putative pathophysiological role of growth factors and cytokines in experimental diabetic kidney disease. Diabetologia 2000; 43: 1205-1223.
49. Ostergard T, Degn KB, Gall MA, et al. The insulin secretagogues glibenclamide and repoglinide do not influence growth hormone secretion in humans but stimulate glucagon secretion during profound insulin deficiency. J Clin Endocrinol Metab 2004; 89: 297-302.
50. Kitabchi AE, Temprosa M, Knowler WC, et al. Role of insulin secretion and sensitivity in the evolution of type 2 diabetes in the Diabetes Prevention Program: effects of lifestyle intervention and metformin. Diabetes 2005; 54: 2404-2414.
51. Levy CJ, Kinsley BT, Bajaj M, et al. Effect of glycaemic control on glucose counterregulation during hypoglycemia in NIDDM. Diabetes Care 1998; 21: 1330-1338.
52. Cryer PE. The pathophysiology of hypoglycaemia in diabetes. Diabetes Nutr Metab 2002; 15: 330-333.
53. Kahn BB. Type 2 diabetes: when insulin secretion fails to compensate for insulin resistance. Cell 1998; 92: 593-596.
54. Owens DR, Zinman B, Bolli GB. Insulins today and beyond. Lancet 2001; 358: 739-746.
55. Owens DR, Luzio SD, Coates PA. Insulin secretion and sensitivity in newly diagnosed NIDDM Caucasians in the UK. Diabet Med 1996; 13: S19-S24.
56. Segel SA, Paramore DS, Cryer PE. Hypoglycemia-associated autonomic failure in advanced type 2 diabetes. Diabetes 2002; 51: 724-733.
57. UK Prospective Diabetes Study Group. United Kingdom Prospective Diabetes Study 24: a 6-year, randomized, controlled trial comparing sulfonylurea, insulin, and metformin therapy in patients with newly diagnosed type 2 diabetes that could not be controlled with diet therapy. Ann Intern Med 1998; 128: 165-175.
58. Burge MR, Sobhy TA, Qualls CR, et al. Effect of short-term glucose control on glycaemic thresholds for epinephrine and hypoglycemic symptoms. J Clin Endocrinol Metab 2001; 86: 5471-5478.
59. Hoffmann J, Spengler M. Efficacy of 24-week monotherapy with acarbose, metformin, or placebo in dietary-treated NIDDM patients: the Essen-II Study. Am J Med 1997; 103: 483-490.
60. Segal P, Feig PU, Schernthaner G, et al. The efficacy and safety of miglitol therapy compared with glibenclamide in patients with NIDDM inadequately controlled by diet alone. Diabetes Care 1997; 20: 687-691.
61. Scott R, Wu M, Sanchez M, et al. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract 2006; 61: 1-10.
62. Papa G, Fedele V, Rizzo MR, et al. Safety of type 2 diabetes treatment with repaglinide compared with glibenclamide in elderly people: a randomized, open-label, two-period, crossover trial. Diabetes Care 2006; 29: 1918-1920.
63. Schatz H. Preclinical and clinical studies on safety and tolerability of repaglinide. Exp Clin Endocrinol Diabetes 1999; 107 (Suppl. 4): S144-S148.
64. Kristensen JS, Frandsen KB, Bayer TH, et al. Repaglinide treatment is associated with significantly less severe hypoglycaemic events compared to sulphonylurea. Diabetologia 1999; 42(Suppl. 1): A4.
65. Fonseca VA, Kelley DE, Cefalu W, et al. Hypoglycemic potential of nateglinide versus glyburide in patients with type 2 diabetes mellitus. Metabolism 2004; 53: 1331-1335.
66. Taki H, Maki T, Iso T, et al. Postmarketing surveillance study of nateglinide in Japan. Adv Ther 2005; 22: 513-526.
67. DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med 1999; 131: 281-303.
68. Lebovitz HE, Melander A. In International Textbook of Diabetes Mellitus, Alberti KGMM, Zimmer P, DeFronzo RA, et al. (eds). John Wiley and Sons: New York, 1997; 817-840.
69. Short RI, Ray WA, Daugherty JR, et al. Individual sulfony-lureas and serious hypoglycemia in older people. J Am Geriatr Soc 1996; 44: 751-755.
70. Einhorn D, Rendell M, Rosenzweig J, et al. Pioglitazone hydrochloride in combination with metformin in the treatment of type 2 diabetes mellitus: a randomized, placebo-controlled study. The Pioglitazone 027 Study Group. Clin Ther 2000; 22: 1395-1409.
71. Fonseca V, Rosenstock J, Patwardhan R, et al. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA 2000; 283: 1695-1702.
72. DeFronzo RA, Ratner RE, Han J, et al. Effects of exenatide (exendin-4) on glycaemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care 2005; 28: 1092-1100.
73. Horton ES, Clinkingbeard C, Gatlin M, et al. Nateglinide alone and in combination with metformin improves glycaemic control by reducing mealtime glucose levels in type 2 diabetes. Diabetes Care 2000; 23: 1660-1665.
74. Van Gaal L, Maislos M, Schernthaner G, et al. Miglitol combined with metformin improves glycaemic control in type 2 diabetes. Diabetes Obes Metab 2001; 3: 326-331.
75. Ahren B, Gomis R, Standl E, et al. Twelve- and 52-week efficacy of the dipeptidyl peptidase IV inhibitor LAF237 in metformin-treated patients with type 2 diabetes. Diabetes Care 2004; 27: 2874-2880.
76. Moses R, Slobodniuk R, Boyages S, et al. Effect of repaglinide addition to metformin monotherapy on glycaemic control in patients with type 2 diabetes. Diabetes Care 1999; 22: 119-124.
77. Jovanovic L, Hassman DR, Gooch B, et al. Treatment of type 2 diabetes with a combination regimen of repaglinide plus pioglitazone. Diabetes Res Clin Pract 2004; 63: 127-134.
78. Kipnes MS, Krosnick A, Rendell MS, et al. Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycaemic control in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study. Am J Med 2001; 111: 10-17.
79. Vongthavaravat V, Wajchenberg BL, Waitman JN, et al. An international study of the effects of rosiglitazone plus sulphonylurea in patients with type 2 diabetes. Curr Med Res Opin 2002; 18: 456-461.
80. Buse JB, Henry RR, Han J, et al. Effects of exenatide (exeridin-4) on glycaemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care 2004; 27: 2628-2635.
81. U.K. Prospective Diabetes Study Group. UKPDS 28: a randomized trial of efficacy of early addition of metformin in sulfonylurea-treated type 2 diabetes. Diabetes Care 1998; 21: 87-92.
82. Rosenstock J, Goldstein BJ, Vinik AI, et al. Effect of early addition of rosiglitazone to sulphonylurea therapy in older type 2 diabetes patients (>60 years): the Rosiglitazone Early vs. SULphonylurea Titration (RESULT) study. Diabetes Obes Metab 2006; 8: 49-57.
83. Madsbad S, Schmitz O, Ranstam J, et al. Improved glycaemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial. Diabetes Care 2004; 27: 1335-1342.
84. Garber AJ. Premixed insulin analogues for the treatment of diabetes mellitus. Drugs 2006; 66: 31-49.
85. Rosenstock J, Dailey G, Massi-Benedetti M, et al. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care 2005; 28: 950-955.
86. Glazer NB, Zalani S, Anderson JH Jr, et al. Safety of insulin lispro: pooled data from clinical trials. Am J Health Syst Pharm 1999; 56: 542-547.
87. Bell DSH. Practical considerations and guidelines for dosing sulfonylureas as monotherapy or combination therapy. Clin Ther 2004; 26: 1714-1727.
88. Banz K, Dinkel R, Hanefeld M, et al. Evaluation of the potential clinical and economic effects of bodyweight stabilisation with acarbose in patients with type 2 diabetes mellitus. A decision-analytical approach. Pharmacoeconomics 1998; 13: 449-459.
89. Inzucchi SE. Oral antihyperglycaemic therapy for type 2 diabetes: scientific review. JAMA 2002; 287: 360-372.
90. Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycaemia 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. Diabetologia 2006; 49: 1711-1721.
91. Bell DSH, Ovalle F. Outcomes of initiation of therapy with once-daily combination of a thiazolidinedione and a biguanide at an early stage of type 2 diabetes. Diabetes Obes Metab 2004; 6: 363-366.
92. Krentz AJ, Bailey CJ. Oral antidiabetic agents: current role in type 2 diabetes mellitus. Drugs 2005; 65: 385-411.
93. Scheen AJ, Lefebvre PJ. Oral antidiabetic agents. A guide to selection. Drugs 1998; 55: 225-236.
94. Ferner RE, Chaplin S. The relationship between the pharmacokinetics and pharmacodynamic effects of oral hypoglycaemic drugs. Clin Pharmacokinet 1987; 12: 379-401.
95. Wahlin-Boll E, Almer LO, Melander A. Bioavailability, pharmacokinetics and effects of glipizide in type 2 diabetics. Clin Pharmacokinet 1982; 7: 363-372.
96. Foley JE, Wang S, Hus S. Glucose-dependent and glucose-sensitizing insulinotropic effects of nateglinide: comparison to glyburide and repaglinide. Diabetologia 2000; 43(Suppl. 1): A127.
97. Malaisse WJ. Mechanism of action of a new class of insulin secretagogues. Exp Clin Endocrinol Diabetes 1999; 107(Suppl. 4): S140-S143.
98. Hu S, Wang S, Dunning BE. Glucose-dependent and glucose-sensitizing insulinotropic effect of nateglinide: comparison to sulfonylureas and repaglinide. Int J Exp Diabetes Res 2001; 2: 63-72.
99. Szoke E, Gosmanov NR, Sinkin JC, et al. Effects of glimepiride and glyburide on glucose counterregulation and recovery from hypoglycemia. Metabolism 2006; 55: 78-83.
100. Abraira C, Henderson WG, Colwell JA, et al. Response to intensive therapy steps and to glipizide dose in combination with insulin in type 2 diabetes. VA feasibility study on glycaemic control and complications (VA CSDM). Diabetes Care 1998; 21: 574-579.
101. Eurich DT, Simpson SH, Majumdar SR, et al. Secondary failure rates associated with metformin and sulfonylurea therapy for type 2 diabetes mellitus. Pharmacotherapy 2005; 25: 810-816.
102. Maedler K, Carr RD, Bosco D, et al. Sulfonylurea induced β-cell apoptosis in cultured human islets. J Clin Endocrinol Metab 2005; 90: 501-506.
103. Peacey SR, Robinson R, Bedford C, et al. Does the choice of treatment for type 2 diabetes affect the physiological response to hypoglycemia? Diabetes Care 2000; 23: 1022-1023.
104. Nattrass M, Lauritzen T. Review of prandial glucose regulation with repaglinide: a solution to the problem of hypoglycaemia in the treatment of Type 2 diabetes? Int J Obes Relat Metab Disord 2000; 24(Suppl. 3): S21-S31.
105. Paolisso G, Rizzo MR, Barbieri M, et al. Cardiovascular risk in type 2 diabetics and pharmacological regulation of mealtime glucose excursions. Diabetes Metab 2003; 29: 335-340.
106. Culy CR, Jarvis B. Repaglinide: a review of its therapeutic use in type 2 diabetes mellitus. Drugs 2001; 61: 1625-1660.
107. Owens DR, McDougall A. Repaglinide: prandial glucose regulation in clinical practice. Diabetes Obes Metab 2000; 2(Suppl. 1): S43-S48.
108. Marbury TC, Ruckle JL, Hatorp V, et al. Pharmacokinetics of repaglinide in subjects with renal impairment. Clin Pharmacol Ther 2000; 67: 7-15.
109. Malaisse WJ. Pharmacology of the meglitinide analogs: new treatment options for type 2 diabetes mellitus. Treat Endocrinol 2003; 2: 401-414.
110. Fuhlendorff J, Rorsman P, Kofod H, et al. Stimulation of insulin release by repaglinide and glibenclamide involves both common and distinct processes. Diabetes 1998; 47: 345-351.
111. Plosker GL, Figgitt DP. Repaglinide: a pharmacoeconomic review of its use in type 2 diabetes mellitus. Pharmacoeconomics 2004; 22: 389-411.
112. Novo Nordisk Pharmaceuticals I. Prandin™ (Repaglinide) Tablets (0.5, 1, and 2 mg). Novo Nordisk Pharmaceuticals: Princeton, NJ, 2006.
113. Novartis Pharmaceuticals Corporation. Starlix® (Nateglinide) Tablets. Novartis Pharmaceuticals Corporation: East Hanover, NJ, 2004.
114. Rosenstock J, Hassman DR, Madder RD, et al. Repaglinide versus nateglinide monotherapy: a randomized, multicenter study. Diabetes Care 2004; 27: 1265-1270.
115. Turner RC, Cull CA, Frighi V, et al. Glycaemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 1999; 281: 2005-2012.
116. Rosenstock J. Treatment strategies and new therapeutic advances for type 2 diabetes. Diabetes Educ 2000; 26 (Suppl.): 14-18.
117. Gerich J, Raskin P, Jean-Louis L, et al. PRESERVE-β: two-year efficacy and safety of initial combination therapy with nateglinide or glyburide plus metformin. Diabetes Care 2005; 28: 2093-2099.
118. Holman RR, Cull CA, Turner RC. A randomized double-blind trial of acarbose in type 2 diabetes shows improved glycaemic control over 3 years (U.K. Prospective Diabetes Study 44). Diabetes Care 1999; 22: 960-964.
119. Aljabri K, Kozak SE, Thompson DM. Addition of pioglitazone or bedtime insulin to maximal doses of sulfonylurea and metformin in type 2 diabetes patients with poor glucose control: a prospective, randomized trial. Am J Med 2004; 116: 230-235.
120. Kendall DM, Riddle MC, Rosenstock J, et al. Effects of exenatide (exendin-4) on glycaemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care 2005; 28: 1083-1091.
121. Raskin P, Klaff L, McGill J, et al. Efficacy and safety of combination therapy: repaglinide plus metformin versus nateglinide plus metformin. Diabetes Care 2003; 26: 2063-2068.
122. Roberts VL, Stewart J, Issa M, et al. Triple therapy with glimepiride in patients with type 2 diabetes mellitus inadequately controlled by metformin and a thiazolidinedione: results of a 30-week, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther 2005; 27: 1535-1547.
123. Yki-Jarvinen H. Combination therapies with insulin in type 2 diabetes. Diabetes Care 2001; 24: 758-767.
124. Sheehan MT. Current therapeutic options in type 2 diabetes mellitus: a practical approach. Clin Med Res 2003; 1: 189-200.
125. Rosak C, Haupt E, Walter T, et al. The effect of combination treatment with acarbose and glibenclamide on postprandial glucose and insulin profiles: additive blood glucose lowering effect and decreased hypoglycaemia. Diabetes Nutr Metab 2002; 15: 143-151.
126. Anderson JH Jr, Brunelle RL, Koivisto VA, et al. Improved mealtime treatment of diabetes mellitus using an insulin analogue. Multicenter Insulin Lispro Study Group. Clin Ther 1997; 19: 62-72.
127. Bastyr EJ III, Huang Y, Brunelle RL, et al. Factors associated with nocturnal hypoglycaemia among patients with type 2 diabetes new to insulin therapy: experience with insulin lispro. Diabetes Obes Metab 2000; 2: 39-46.
128. Ross SA, Zinman B, Campos RV, et al. A comparative study of insulin lispro and human regular insulin in patients with type 2 diabetes mellitus and secondary failure of oral hypoglycemic agents. Clin Invest Med 2001; 24: 292-298.
129. Bretzel RG, Arnolds S, Medding J, et al. A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes. Diabetes Care 2004; 27: 1023-1027.
130. Dailey G, Rosenstock J, Moses RG, et al. Insulin glulisine provides improved glycaemic control in patients with type 2 diabetes. Diabetes Care 2004; 27: 2363-2368.
131. Raslova K, Bogoev M, Raz I, et al. Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes. [Correction appears in Raslova K, et al. Diabetes Res Clin Pract. 2006; 72: 112]. Diabetes Res Clin Pract 2004; 66: 193-201.
132. Raslova K, Bogoev M, Raz I, et al. Corrigendum to "Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes" i Diabetes Res Clin Pract. 66 (2004) 193-201]. Diabetes Res Clin Pract 2006; 72: 112.
133. Nattrass M, Kim H, Draeger E. Lower risk of nocturnal hypoglycaemia with insulin detemir versus NPH insulin in people with diabetes: a meta-analysis of controlled phase III trials. Diabetologia 2004; 47(Suppl. 1): A326-A327.
134. Haak T, Tiengo A, Draeger E, et al. Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes. Diabetes Obes Metab 2005; 7: 56-64.
135. Yokoyama H. Tada J, Kamikawa F, et al. 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.
136. Roach P, Trautmann M, Arora V, et al. Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin-protamine formulations, insulin lispro Mix25. Clin Ther 1999; 21: 523-534.
137. Roach P, Yue L, Arora V. Improved postprandial glycaemic control during treatment with Humalog Mix25, a novel protamine-based insulin lispro formulation. Humalog Mix25 Study Group. Diabetes Care 1999; 22: 1258-1261.
138. Boehm B, Home P, Kamp N, et al. Biphasic insulin aspart and biphasic human insulin compared in type 2 diabetic subjects. Diabetologia 2001; 44(Suppl. 1): A210.
139. Christiansen JS, Vaz JA, Metelko Z, et al. Twice daily biphasic insulin aspart improves postprandial glycaemic control more effectively than twice daily NPH insulin, with low risk of hypoglycaemia, in patients with type 2 diabetes. Diabetes Obes Metab 2003; 5: 446-454.
140. McNally PG, Dean JD, Morris AD, et al. Reduced night-time rates of low interstitial glucose with biphasic insulin aspart 70/30 compared with biphasic human insulin 70/30: a double-blind crossover CGMS study in patients with type 2 diabetes. Diabetes Care 2007; 30: 1044-1048.
141. Odegard PS, Capoccia KL. Inhaled insulin: Exubera. Ann Pharmacother 2005; 39: 843-853.
142. Hollander PA, Blonde L, Rowe R, et al. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with type 2 diabetes: results of a 6-month, randomized, comparative trial. Diabetes Care 2004; 27: 2356-2362.
143. Stehouwer MH, Devries JH, Lumeij JA, et al. Combined bedtime insulin-daytime sulphonylurea regimen compared with two different daily insulin regimens in type 2 diabetes: effects on HbA1c and hypoglycaemia rate-a randomised trial. Diabetes Metab Res Rev 2003; 19: 148-152.
144. Yki-Jarvinen H, Dressler A, Ziemen M. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. Diabetes Care 2000; 23: 1130-1136.
145. Rosenstock J, Schwartz SL, Clark CM Jr, et al. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabetes Care 2001; 24: 631-636.
146. 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: 3080-3086.
147. Fritsche A, Schweitzer MA, Haring HU. Glimepiride combined with morning insulin glargine, bedtime neutral protamine Hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med 2003; 138: 952-959.
148. 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: 442-451.
149. Bullano MF, Al-Zakwani IS, Fisher MD, et al. Differences in hypoglycemia event rates and associated cost-consequence in patients initiated on long-acting and intermediate-acting insulin products. Curr Med Res Opin 2005; 21: 291-298.
150. Raskin P, Braceras R, Schwartz S, at al. Over 75% of patients with type 2 diabetes reached target A1C by adding biphasic insulin aspart 70/ 30 to optimized metformin and pioglitazone treatment. Diabetes 2006; 55(Suppl. 1): A131.
151. Malone JK, Kerr LF, Campaigne BN, at 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: 2034-2044.
152. Malone JK, Bai S, Campaigne BN, et al. Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with type 2 diabetes. Diabet Med 2005; 22: 374-381.
153. 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: 260-265.
154. 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-naive people with type 2 diabetes. Diabetes Care 2006; 29: 1269-1274.
155. Philis-Tsimikas A, Charpentier G, Clauson P, et al. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antiodiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006; 28: 1569-1581.
156. Hollander PA, Levy P, Fineman MS, et al. Pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care 2003; 26: 784-790.
157. Ratner RE, Want LL, Fineman MS, et al. Adjunctive therapy with the amylin analogue pramlintide leads to a combined improvement in glycaemic and weight control in insulin-treated subjects with type 2 diabetes. Diabetes Technol Ther 2002; 4: 51-61.
158. Li Y, Xu W, Liao Z, et al. Induction of long-term glycaemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care 2004; 27: 2597-2602.
159. Marre M. Before oral agents fail: the case for starting insulin early. Int J Obes Relat Metab Disord 2002; 26(Suppl. 3): S25-S30.
160. Leese GP, Wang J, Broomhall J, et al. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care 2003; 26: 1176-1180.
161. Hirsch IB. Insulin analogues. N Engl J Med 2005; 352: 174-183.
162. Niskanen L, Jensen LE, Rastam J, et al. Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. Clin Ther 2004; 26: 531-540.
163. Novo Nordisk. NOVOLOGO® (Novo Nordisk) Insulin Aspart (rDNA origin) Injection [Prescribing Information]. Novo Nordisk: Princeton, NJ, 2005.
164. Eli Lilly and Company. Humalog® (Insulin Lisro Injection [rDNA origin]) Prescribing Information. Eli Lilly and Company: Indianapolis, IN, 2004.
165. Kamal AD, Dixon AN, Bain SC. Safety and side effects of the insulin analogues. Expert Opin Drug Saf 2006; 5: 131-143.
166. Siebenhofer A, Plank J, Berghold A, et al. Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus. Cochrane Database Syst Rev 2004; 4: CD003287-Y.
167. Cox SL. Insulin glulisine. Drugs Today (Barc) 2005; 41: 433-440.
168. Gin H, Hanaire-Broutin H. Reproducibility and variability in the action of injected insulin. Diabetes Metab 2005; 31: 7-13.
169. Mathieu C. Can we reduce hypoglycaemia with insulin detemir? Int J Obes 2004; 28(Suppl. 2): S35-S40.
170. Heise T, Nosek L, Ronn BB, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004; 53: 1614-1620.
171. Meneghini LF, Rosenberg KH, Koenen C, et al. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab 2007; 9: 418-427.
172. Hermansen K, Fontaine P, Kukolja KK, et al. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basalbolus therapy for patients with type 1 diabetes. Diabetologia 2004; 47: 622-629.
173. Davidson J, Vexiau P, Cucinotta D, et al. Biphasic insulin aspart 30: literature review of adverse events associated with treatment. Clin Ther 2005; 27(Suppl. B): S75-S88.
174. Rolla AR, Rakel RE. Practical approaches to insulin therapy for type 2 diabetes mellitus with premixed insulin analogues. Clin Ther 2005; 27: 1113-1125.
175. Strowig SM, Raskin P. Combination therapy using metformin or thiazolidinediones and insulin in the treatment of diabetes mellitus. Diabetes Obes Metab 2005; 7: 633-641.
176. Valverde I, Villanueva-Penacarrillo ML, Malaisse WJ. Pancreatic and extrapancreatic effects of GLP-1. Diabetes Metab 2002; 28: 3S85-3S89.
177. Fehse F, Trautmann M, Holst JJ, et al. Exenatide augments first- and second-phase insulin secretion in response to intravenous glucose in subjects with type 2 diabetes. J Clin Endocrinol Metab 2005; 90: 5991-5997.
178. Gleeson JM, Berenbeim DM, Gilkin RJ. Incretin mimetics: promising new therapeutic options in the treatment of type 2 Diabetes. J Manag Care Pharm 2005; 11(Suppl. 7): S2-S15.
179. Amylin Pharmaceuticals I. Byetta™ (Exenatide Injection) [Prescribing Information]. Amylin Pharmaceuticals, Inc: San Diego, 2005.
180. Meier JJ, Nauck MA, GLP-1, incretin mimetics and DPP 4 inhibitors: new ways in the treatment of type 2 diabetes. Curr Med Chem 2005; 5/6: 485-497.
181. Gautier JF, Fetita S, Sobngwi E, et al. Biological actions of the incretins GIP and GLP-1 and therapeutic perspectives in patients with type 2 diabetes. Diabetes Metab 2005; 31: 233-242.
182. Kleppinger EL, Vivian EM. Pramlintide for the treatment of diabetes mellitus. Ann Pharmacother 2003; 37: 1082-1089.
183. Kruger DF, Gloster MA. Pramlintide for the treatment of insulin-requiring diabetes mellitus: rationale and review of clinical data. Drugs 2004; 64: 1419-1432.
184. Sotiropoulos A, Skliros EA, Tountas C, et al. Risk factors for severe hypoglycaemia in type 2 diabetic patients admitted to hospital in Piraeus, Greece. East Mediterr Health J 2005; 11: 485-489.
185. Murata GH, Duckworth WC, Shah JH, et al. Hypoglycemia in stable, insulin-treated veterans with type 2 diabetes; A prospective study of 1662 episodes. J Diabetes Complicat 2005; 19: 10-17.
186. Galassetti P, Mann S, Tate D, et al. Effects of antecedent prolonged exercise on subsequent counterregulatory responses to hypoglycemia. Am J Physiol Endocrinol Metab 2001; 280: E908-E917.
187. Camacho RC, Galassetti P, Davis SN, et al. Glucoregulation during and after exercise in health and insulin-dependent diabetes. Exerc Sport Sci Rev 2005; 33: 17-23.
188. MacDonald MJ. Postexercise late-onset hypoglycemia in insulin-dependent diabetic patients. Diabetes Care 1987; 10: 584-588.
189. Dagogo-Jack S. Hypoglycemia in type 1 diabetes mellitus: pathophysiology and prevention. Treat Endocrinol 2004; 3: 91-103.
190. Larsen JJ, Dela F, Madsbad S, et al. Interaction of sulfonylureas and exercise on glucose homeostasis in type 2. Diabetes Care 1999;22: 1647-1654.
191. Massi-Benedetti M, Herz M, Pfeiffer C. The effects of acute exercise on metabolic control in type II diabetic patients treated with glimepiride or glibenclamide. Horm Metab Res 1996; 28: 451-455.
192. Bagdade JD, Gale CC, Porte D Jr. Hormone fuel interrelationships during alcohol hypoglycemia in man. Proc Soc Exp Biol Med 1972; 141: 540-542.
193. Kerr D, Macdonald LA, Heller SR, et al. Alcohol causes hypoglycaemic unawareness in healthy volunteers and patients with type 1 (insulin-dependent) diabetes. Diabetologia 1990; 33: 216-221.
194. Cheyne EH, Sherwin RS, Lunt MJ, et al. Influence of alcohol on cognitive performance during mild hypoglycaemia; implications for Type 1 diabetes. Diabet Med 2004; 21: 230-237.
195. Cox D, Gonder-Frederick L, Ritterband L, et al. Factors that identify TIDM drivers at risk for future hypoglycemia-related driving mishaps. Diabetes 2006; 55(Suppl. 1): 617P.
196. Burge MR, Zeise TM, Sobhy TA, et al. Low-dose ethanol predisposes elderly fasted patients with type 2 diabetes to sulfonylurea-induced low blood glucose. Diabetes Care 1999; 22: 2037-2043.
197. Davis WA, Bruce DG, Davis TM. Is self-monitoring of blood glucose appropriate for all type 2 diabetic patients? The Fremantle Diabetes Study. Diabetes Care 2006; 29: 1764-1770.
198. Cox DJ, Gonder-Frederick L, Ritterband L, et al. Prediction of severe hypoglycemia. Diabetes Care 2007; 30: 1370-1373.
199. Albisser AM, Wright CE, Sakkal S. Averting iatrogenic hypoglycemia through glucose prediction in clinical practice: progress towards a new procedure in diabetes. Diabetes Res Clin Pract 2007; 76: 207-214.
200. Hoffman RM, Shah JH, Wendel CS, et al. Evaluating once- and twice-daily self-monitored blood glucose testing strategies for stable insulin-treated patients with type 2 diabetes: the Diabetes Outcomes in Veterans Study. Diabetes Care 2002; 25: 1744-1748.
201. Wysocki T. The psychological context of SMBG. Diabetes Spectrom 1994; 7: 266-270.
202. Solnica B, Naskalski JW. Quality control of SMBG in clinical practice. Scand J Clin Lab Invest 2005; 65(Suppl. 240): 80-85.
203. Capaldi B. Treatments and devices for future diabetes management. Nurs Times 2005; 101: 30-32.
204. Cygnus. GlucoWatch® G2 Automatic Glucose Biographer and Autosensors [Patient Information]. Cygnus: Redwood City, CA, 2002.
205. Hovorka R. Continuous glucose monitoring and closed-loop systems. Diabet Med 2006; 23: 1-12.
206. Bode BW, Tamborlane WV, Davidson PC. Insulin pump therapy in the 21st century. Strategies for successful use in adults, adolescents, and children with diabetes. Postgrad Med 2002; 111: 69-77.
207. Raskin P, Bode BW, Marks JB, et al. Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes: a randomized, parallel-group, 24-week study. Diabetes Care 2003; 26: 2598-2603.
208. Herman WH, Ilag LL, Johnson SL, et al. A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care 2005; 28: 1568-1573.
209. Weissberg-Benchell J, Antisdel-Lomaglio J, Seshadri R. Insulin pump therapy: a meta-analysis. Diabetes Care 2003; 26: 1079-1087.
210. Retnakaran R, Hochman J, Devries JH, et al. Continuous subcutaneous insulin infusion versus multiple daily injections: the impact of baseline A1C. Diabetes Care 2004; 27: 2590-2596.
211. Weinzimer SA, Doyle EA, Steffen AT, et al. Rediscovery of insulin pump treatment of childhood type 1 diabetes. Minerva Med 2004; 95: 85-92.
212. Radermecker RP, Scheen AJ. Continuous subcutaneous insulin infusion with short-acting insulin analogues or human regular insulin: efficacy, safety, quality of life, and cost-effectiveness. Diabetes Metab Res Rev 2004; 20: 178-188.
213. Colquitt JL, Green C, Sidhu MK, et al. Clinical and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes. Health Technol Assess 2004; 8(43): 1-186.
214. Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes. Diabetes Care 1996; 19: 324-327.
215. Siebenhofer A, Plank J, Berghold A, et al. Meta-analysis of short-acting insulin analogues in adult patients with type 1 diabetes: continuous subcutaneous insulin infusion versus injection therapy. Diabetologia 2004; 47: 1895-1905.
216. Murata GH, Duckworth WC, Shah JH, et al. Factors affecting hypoglycemia awareness in insulin-treated type 2 diabetes: The Diabetes Outcomes in Veterans Study (DOVES). Diabetes Res Clin Pract 2004; 65: 61-67.
217. Plank J, Kohler G, Rakovac I, et al. Long-term evaluation of a structured outpatient education programme for intensified insulin therapy in patients with Type 1 diabetes: a 12-year follow-up. Diabetologia 2004; 47: 1370-1375.
218. Cox DJ, Kovatchev B, Koev D, et al. Hypoglycemia anticipation, awareness and treatment training (HAATT) reduces occurrence of severe hypoglycemia among adults with type 1 diabetes mellitus. Int J Behav Med 2004; 11: 212-218.
219. Zrebiec JA. National study of the certified diabetes educator: report on a job analysis conducted by the national certification board for diabetes educators. Diabetes Spectrom 2005; 18: 181-185.