Insulin monotherapy versus combinations of insulin with oral hypoglycaemic agents in patients with type 2 diabetes mellitus

Cochrane Database of Systematic Reviews

Volumn 2009, Issue 1, 2004, Pages

  Goudswaard, Alex N ^a   Furlong, Niall J ^b   Valk, Gerlof D ^c   Stolk, Ronald P ^d   Rutten, Guy EHM ^c  

^a DUTCH COLLEGE OF GENERAL PRACTITIONERS   (Netherlands)

^b WHISTON HOSPITAL   (United Kingdom)

^c UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^d UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; INSULIN;

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG COMBINATION; HUMAN; META ANALYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL; REVIEW;

DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; RANDOMIZED CONTROLLED TRIALS;

EID: 16644372491     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD003418.pub2     Document Type: Review

References (169)

1. Bachmann W, Lotz N, Mehnert H, Rosak C, Schoffling K. [Effectiveness of combined treatment with glibenclamide and insulin in secondary sulfonylurea failure. A controlled multicenter double-blind clinical trial]. Deutsche Medizinische Wochenschrift 1988;113(16):631-36. [MEDLINE: 3832]
2. Bastyr EJ, Johnson ME, Trautmann ME, Anderson JH, Vignati L. Insulin lispro in the treatment of patients with type 2 diabetes mellitus after oral agent failure. Clinical Therapeutics 1999;21(10):1703-14.
3. Chow CC, Tsang LW, Sorensen JP, Cockram CS. Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients. Diabetes Care 1995;18(3):307-14.
4. Fövényi J, Grosz A, Thaisz E, Lehotkai, L, Sallai T, Kocsis G. [Daytime sulfonyluyrea - bedtime insulin combination therapy in Type II diabetes]. Magy Belorv Arch (Hungarian Archive of Internal Medicine) 1997;50:607-13.
5. Gutniak M, Karlander SG, Efendic S. Glyburide decreases insulin requirement, increases beta-cell response to mixed meal, and does not affect insulin sensitivity: effects of short- and long-term combined treatment in secondary failure to sulfonylurea. Diabetes Care 1987;10(5):545-54.
6. Holman RR, Steemson J, Turner RC. Sulphonylurea failure in type 2 diabetes: treatment with a basal insulin supplement. Diabetic Medicine 1987;4(5):457-62.
7. Karlander SG, Gutniak MK, Efendic S. Effects of combination therapy with glyburide and insulin on serum lipid levels in NIDDM patients with secondary sulfonylurea failure. Diabetes Care 1991;14(11):963-67.
8. Lotz N, Bachmann W, Ladik T, Mehnert H. [Combination therapy with insulin/sulfonylurea in the long-term therapy of type II diabetes following "secondary failure"]. [German]. Klinische Wochenschrift 1988;66(21):1079-84.
9. Lundershausen R, Orban S, Pissarek D, Panzram G. [Long-term effect of combination glibenclamide-insulin treatment in the secondary failure of sulfonylurea therapy--results of a one-year double blind study]. [German]. Wiener Klinische Wochenschrift 1987;99(17):603-8.
10. Mäkimattila S, Nikkila 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(4):406-12.
11. Pontiroli AE, Dino G, Capra F, Pozza G. Combined therapy with glibenclamide and ultralente insulin in lean patients with NIDDM with secondary failure of sulfonylureas. Follow up at two years. Diabete et Metabolisme 1990;16(4):323-27.
12. Ravnik-Oblak M, Mrevlje F. Insulin versus a combination of insulin and sulfonylurea in the treatment of NIDDM patients with secondary oral failure. Diabetes Research & Clinical Practice 1995;30(1):27-35.
13. Riddle MC, Hart JS, Bouma DJ, Phillipson BE, Youker G. Efficacy of bedtime NPH insulin with daytime sulfonylurea for subpopulation of type II diabetic subjects. Diabetes Care 1989;12(9):623-29. [MEDLINE: 1]
14. Riddle M, Hart J, Bingham P, Garrison C, McDaniel P. Combined therapy for obese type 2 diabetes: suppertime mixed insulin with daytime sulfonylurea. American Journal of the Medical Sciences 1992;303(3):151-56.
15. Riddle MC, Schneider J. Beginning insulin treatment of obese patients with evening 70/30 insulin plus glimepiride versus insulin alone. Glimepiride Combination Group. Diabetes Care 1998;21(7):1052-57.
16. Shank ML, Del Prato S, DeFronzo RA. Bedtime insulin/daytime glipizide. Effective therapy for sulfonylurea failures in NIDDM. Diabetes 1995;44:165-72.
17. Sun Y, Xiong Y, Yang J. [The effectiveness of combined insulin and sulfonylurea in treating non-insulin dependent diabetic patients]. [Chinese]. Chung-Hua Nei Ko Tsa Chih Chinese Journal of Internal Medicine 1995;34(4):246-49.
18. Wolffenbuttel BH, Rondas-Colbers GJ, Menheere PP, Sels JP, Nieuwenhuijzen-Kruseman AC. [The effects of insulin combined with glibenclamide on glucose and lipid metabolism in patients with Type II diabetes mellitus]. Ned Tijdschr Geneeskd 1991;135:1080-84.
19. Wolffenbuttel BH, Sels JP, Rondas-Colbers GJ, Menheere PP, Nieuwenhuijzen-Kruseman AC. Comparison of different insulin regimens in elderly patients with NIDDM. Diabetes Care 1996;19:1326-32.
20. Xu WC, Chen CR, Chen YS. Combination therapy with bedtime insulin and daytime oral hypoglycaemic agents in type 2 diabetic patients [Chinese]. Hebei Medicine 2001;23:23-24. [MEDLINE: 7231]
21. Yki-Järvinen H, Kauppila M, Kujansuu E, Lahti J, Marjanen T, Niskanen L, et al. Comparison of insulin regimens in patients with non-insulin-dependent diabetes mellitus. New England Journal of Medicine 1992;327(20):1426-33.
22. Yki-Järvinen H, Ryysy L, Nikkila K, Tulokas T, Vanamo R, Heikkila M. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial. Annals of Internal Medicine 1999;130(5):389-96.
23. Allen BT, Feinglos MN, Lebovitz HE. Treatment of poorly regulated non-insulin-dependent diabetes mellitus with combination insulin-sulfonylurea. Arch Intern Med 1985;145(10):1900-03.
24. Aviles-Santa L, Sinding J, Raskin P. Effects of metformin in patients with poorly controlled, insulin-treated type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled trial. Annals of Internal Medicine 1999;131(3):182-88.
25. Bastyr EJ, Stuart CA, Brodows RG, Schwartz S, Graf CJ, Zagar A, et al. Therapy focused on lowering postprandial glucose, not fasting glucose, may be superior for lowering HbA1c. IOEZ Study Group. [see comments]. Diabetes Care 2000;23(9):1236-41.
26. Bieger WP, Dlugosch R, Rettenmeier A, Holler HD, Bert H, Schwarz W, et al. Trial of sulfonylurea in combination with insulin in the therapy of diabetes type I and II. Evidence against a primary extrapancreatic receptor effect. Klinische Wochenschrift 1984;62(13):631-39.
27. Birkeland KI, Hanssen KF, Urdal P, Berg K, Vaaler S. A long-term, randomized, comparative study of insulin versus sulfonylurea therapy in type 2 diabetes [see comments]. Journal of Internal Medicine 1994;236:305-13.
28. Birkeland KI, Rishaug U, Hanssen KF, Vaaler S. NIDDM: a rapid progressive disease. Results from a long-term, randomised, comparative study of insulin or sulphonylurea treatment. Diabetologia 1996;39:1629-33.
29. Bruns W, Willkommen G, Philipp A, Czeczatka W, Hildebrandt R, Jutzi E. Zur Behandlung von Typ II (non-insulin-dependent)-Diabetikern mit Sulfonylharnstoff-Sekundärversagen Kombinationstherapie von Glibenclamid und Insulin. Zeitschrift für Klinische Medizin 1988;43:625-29. [MEDLINE: 7232]
30. Calle-Pascual AL, Garcia HJ, Martin-Alvarez PJ, Vara E, Calle JR, Munguira ME, et al. Comparison between acarbose, metformin, and insulin treatment in type 2 diabetic patients with secondary failure to sulfonylurea treatment. Diabetes and Metabolism 1995;21:256-60.
31. Camerini-Davalos RA BJJV. Effect of insulin-glipizide combination on skeletal muscle capillary basement membrane width in diabetic patients. Clinical Therapeutics 1994;16(6):952-61.
32. Carta Q, Trovati M, Dani F, Caselle MT, Vitali S, Cavalot F, et al. [Insulin or insulin + oral hypoglycemic drugs in the treatment of type 2 diabetes difficult to compensate metabolically?]. [Italian]. Minerva Endocrinologica 1984;9(2):241-45.
33. Casner PR. Insulin-glyburide combination therapy for non-insulin-dependent diabetes mellitus: a long-term double-blind, placebo-controlled trial. Clinical Pharmacology & Therapeutics 1988;44(5):594-603.
34. Castillo M, Scheen AJ, Paolisso G, Lefebvre PJ. The addition of glipizide to insulin therapy in type-II diabetic patients with secondary failure to sulfonylureas is useful only in the presence of a significant residual insulin secretion. Acta Endocrinologica 1987;116(3):364-72.
35. Chazan AC, Gomes MB. Gliclazide and bedtime insulin are more efficient than insulin alone for type 2 diabetic patients with sulfonylurea secondary failure. Brazilian Journal of Medical & Biological Research 2001;34(1):49-56.
36. Chiasson JL, Josse RG, Hunt JA, Palmason C, Rodger NW, Ross SA. The efficacy of acarbose in the treatment of patients with non-insulin-dependent diabetes mellitus. A multicenter controlled clinical trial. Annals of Internal Medicine 1994;121(12):928-35. [MEDLINE: 27]
37. Clauson P, Karlander S, Steen L, Efendic S. Daytime glibenclamide and bedtime NPH insulin compared to intensive insulin treatment in secondary sulphonylurea failure: a 1-year follow-up. Diabetic Medicine 1996;13(5):471-77.
38. Cortes AH, Espinosa Lopez FR, Angulo Cervera JA, Diaz TJ. [A comparative study of insulin and glyburide versus glyburide or insulin in the chronic control of patients with type-2 diabetes]. [Spanish]. Gaceta Medica de Mexico 1993;129(6):383-86.
39. Diehl AK, Sugarek NJ, Bauer RL. Medication compliance in non-insulin-dependent diabetes: a randomized comparison of chlorpropamide and insulin. Diabetes Care 1985;8:219-23.
40. Elgrably F, Costagliola D, Chwalow AJ, Varenne P, Slama G, Tchobroutsky G. Initiation of insulin treatment after 70 years of age: patient status 2 years later. Diabet Med 1991;8(8):773-77. [MEDLINE: 3682]
41. Falko JM, Osei K. Combination insulin/glyburide therapy in type II diabetes mellitus. Effects on lipoprotein metabolism and glucoregulation. American Journal of Medicine 1985;79(3B):92-101.
42. Feinglos MN, Thacker CH, English J, Bethel MA, Lane JD. Modification of postprandial hyperglycemia with insulin lispro improves glucose control in patients with type 2 diabetes. Diabetes Care 1997;20(10):1539-42.
43. Feinglos MN, Thacker CR, Lobaugh B, DeAtkine DD, McNeill DB, English JS. Combination insulin and sulfonylurea therapy in insulin-requiring type 2 diabetes mellitus. Diabetes Research & Clinical Practice 1998;39(3):193-99.
44. Firth RG, Bell PM, Rizza RA. Effects of tolazamide and exogenous insulin on insulin action in patients with non-insulin-dependent diabetes mellitus. The New England Journal of Medicine 1986;314:1280-86.
45. Firth R, Bell P, Marsh M, Rizza RA. Effects of tolazamide and exogenous insulin on pattern of postprandial carbohydrate metabolism in patients with non-insulin- dependent diabetes mellitus. Results of randomized crossover trial. Diabetes 1987;36:1130-38.
46. Fonseca V, Foyt HL, Shen K, Whitcomb R. Long-term effects of troglitazone: open-label extension studies in type 2 diabetic patients. Diabetes Care 2000;23(3):354-59. [MEDLINE: 7231]
47. Fritsche A, Schmulling RM, Haring HU, Stumvoll M. Intensive insulin therapy combined with metformin in obese type 2 diabetic patients. Acta Diabetologica 2000;37(1):13-18.
48. Giugliano D, Quatraro A, Consoli G, Minei A, Ceriello A, De Rosa N, et al. Metformin for obese, insulin-treated diabetic patients: improvement in glycaemic control and reduction of metabolic risk factors. European Journal of Clinical Pharmacology 1993;44(2):107-12. [MEDLINE: 4664]
49. Groop L, Harno K, Tolppanen EM. The combination of insulin and sulphonylurea in the treatment of secondary drug failure in patients with type II diabetes. Acta Endocrinologica 1984;106(1):97-101.
50. Groop L, Harno K, Nikkila EA, Pelkonen R, Tolppanen EM. Transient effect of the combination of insulin and sulfonylurea (glibenclamide) on glycemic control in non-insulin dependent diabetics poorly controlled with insulin alone. Acta Medica Scandinavica 1985;217(1):33-39.
51. Groop L, Widen E, Franssila-Kallunki A, Ekstrand A, Saloranta C, Schalin, C, et al. Different effects of insulin and oral antidiabetic agents on glucose and energy metabolism in type 2 (non-insulin-dependent) diabetes mellitus. Diabetologia 1989;32(8):599-605.
52. Groop L, Widen E. Treatment strategies for secondary sulfonylurea failure. Should we start insulin or add metformin? Is there a place for intermittent insulin therapy?. Diabete et Metabolisme 1991;17(1 Pt 2):218-23.
53. Groop LC, Widen E, Ekstrand A, Saloranta C, Franssila-Kallunki A, Schalin-Jantti C, et al. Morning or bedtime NPH insulin combined with sulfonylurea in treatment of NIDDM. Diabetes Care 1992;15(7):831-34.
54. Guvener N, Gedik O. Effects of combination of insulin and acarbose compared with insulin and gliclazide in type 2 diabetic patients. Acta Diabetologica 1999;36(1-2):93-97.
55. Hamelbeck H, Klein W, Zoltobrocki M, Schoffling K. [Glibenclamide-insulin combination in the management of secondary failure of sulfonyl-urea medication]. Deutsche Medizinische Wochenschrift 1982;107(42):1581-83. [MEDLINE: 7230]
56. Hirsch IB. Metformin added to insulin therapy in poorly controlled type 2 diabetes. Diabetes Care 1999;22(5):854.
57. Josse RG. Acarbose for the treatment of type II diabetes: the results of a Canadian multi-centre trial. [erratum appears in Diabetes Res Clin Pract 1995 Sep;29(3):215]. Diabetes Research & Clinical Practice 1995;28 Suppl:S167-S172.
58. Kasim SE, LeBoeuf RC, Rockett MJ, Page J, Keyser AJ. The effects of oral agent or insulin treatments on the plasma lipoproteins and the plasma lipoprotein lipase activator in diabetic patients. Hormone & Metabolic Research 1986;18(3):190-93.
59. Kelley DE, Bidot P, Freedman Z, Haag B, Podlecki D, Rendell M, et al. Efficacy and safety of acarbose in insulin-treated patients with type 2 diabetes. Diabetes Care 1998;21(12):2056-61. [MEDLINE: 49]
60. Kitabchi AE, Soria AG, Radparvar A, Lawson-Grant V. Combined therapy of insulin and tolazamide decreases insulin requirement and serum triglycerides in obese patients with noninsulin-dependent diabetes mellitus. American Journal of the Medical Sciences 1987;294(1):10-14.
61. Klein W. Sulfonylurea-metformin-combination< /strong> versus sulfonylurea-insulin-combination in secondary failures of sulfonylurea monotherapy. Results of a prospective randomized study in 50 patients. Diabete et Metabolisme 1991;17(1 Pt 2):235-40.
62. Kyllastinen M, Groop L. Combination of insulin and glibenclamide in the treatment of elderly non-insulin dependent (type 2) diabetic patients. Annals of Clinical Research 1985;17(3):100-04.
63. Landstedt-Hallin L, Adamson U, Arner P, Bolinder J, Lins PE. Comparison of bedtime NPH or preprandial regular insulin combined with glibenclamide in secondary sulfonylurea failure. Diabetes Care 1995;18(8):1183-86. [MEDLINE: 38]
64. Landstedt-Hallin L, Arner P, Lins PE, Bolinder J, Olsen H, Groop L. The role of sulphonylurea in combination therapy assessed in a trial of sulphonylurea withdrawal. Scandinavian Insulin-Sulphonylurea Study Group Research Team. Diabetic Medicine 1999;16(10):827-34.
65. Lardinois CK, Liu GC, Reaven GM. Glyburide in non-insulin-dependent diabetes. Its therapeutic effect in patients with disease poorly controlled by insulin alone. Archives of Internal Medicine 1985;145(6):1028-32.
66. Lawrence AM, Abraira C. New modalities in diabetes treatment. The American journal of medicine 1988;85:153-58.
67. Lebovitz HE, Pasmantier R. Combination insulin-sulfonylurea therapy. Diabetes Care 1990;13(6):667-75. [MEDLINE: 6429]
68. Lewitt MS, Yu VK, Rennie GC, Carter JN, Marel GM, Yue DK, et al. Effects of combined insulin-sulfonylurea therapy in type II patients. [see comments]. Diabetes Care 1989;12(6):379-83.
69. Liedtke RK SMM. Transdermal insulin application in type II diabetic patients. Results of a clinical pilot study. Arzneimittel-Forschung Drug Research 1990;40(8):884-86.
70. Lindstrom T, Arnqvist HJ, Ludvigsson J, von Schenck HH. C-peptide profiles in patients with non-insulin-dependent diabetes mellitus before and during insulin treatment. Acta Endocrinologica 1992;126(6):477-83.
71. Lindstrom T, Nystrom FH, Olsson AG, Ottosson AM, Arnqvist HJ. The lipoprotein profile differs during insulin treatment alone and combination therapy with insulin and sulphonylureas in patients with Type 2 diabetes mellitus. Diabetic Medicine 1999;16(10):820-26.
72. Lins PE, Lundblad S, Persson-Trotzig E, Adamson U. Glibenclamide improves the response to insulin treatment in non-insulin-dependent diabetics with second failure to sulfonylurea therapy. Acta Medica Scandinavica 1988;223(2):171-79.
73. Longnecker MP, Elsenhans VD, Leiman SM, Owen OE, Boden G. Insulin and a sulfonylurea agent in non-insulin-dependent diabetes mellitus. Archives of Internal Medicine 1986;146(4):673-76.
74. Lopez-Alvarenga JC, Aguilar-Salinas CA, Velasco-Perez ML, Arita-Melzer O, Guillen LE, Wong B, et al. Acarbose vs. bedtime NPH insulin in the treatment of secondary failures to sulphonylurea-metformin therapy in type 2 diabetes mellitus. Diabetes Obesity & Metabolism 1999;1(1):29-35.
75. Martin DB. Type II diabetes: insulin versus oral agents. New England Journal of Medicine 1986;314(20):1314-15.
76. Mauerhoff T, Ketelslegers JM, Lambert AE. Effect of glibenclamide in insulin-treated diabetic patients with a residual insulin secretion. Diabete et Metabolisme 1986;12(1):34-38.
77. Mezitis NH, Heshka S, Saitas V, Bailey TS, Costa R, Pi-Sunyer FX. Combination therapy for NIDDM with biosynthetic human insulin and glyburide. Diabetes Care 1992;15(2):265-69.
78. Mohan V, Snehalatha C, Ramachandran A, Viswanathan M. Combination therapy of glibenclamide and insulin in NIDDM patients with secondary failure to oral drugs. [see comments]. Journal of the Association of Physicians of India 1990;38(8):537-41.
79. Nathan DM, Roussell A, Godine JE. Glyburide or insulin for metabolic control in non-insulin-dependent diabetes mellitus. A randomized, double-blind study. Annals of Internal Medicine 1988;108(3):334-40.
80. Niazi R, Muzaffar Z. Comparison of bedtime NPH insulin or metformin combined with glibenclamide in secondary sulphonylurea failure in obese type II (NIDDM) patients. JPMA - Journal of the Pakistan Medical Association 1998;48(11):336-38.
81. Niskanen L, Lahti J, Uusitupa M. Morning or bed-time insulin with or without glibenclamide in elderly type 2 diabetic patients unresponsive to oral antidiabetic agents. Diabetes Res Clin Pract 1992;18:185-90.
82. Okada S. The effect of an alpha-glucosidase inhibitor and insulin on glucose metabolism and lipid profiles in non-insulin-dependent diabetes mellitus. Journal of International Medical Research 1996;24(5):438-47.
83. Osei K, O'Dorisio TM, Falko JM. Concomitant insulin and sulfonylurea therapy in patients with type II diabetes. Effects on glucoregulation and lipid metabolism. American Journal of Medicine 1984;77(6):1002-09.
84. Panahloo A, Mohamed Ali V, Andres C, Denver AE, Yudkin JS. Effect of insulin versus sulfonylurea therapy on cardiovascular risk factors and fibrinolysis in type II diabetes. Metabolism: Clinical & Experimental 1998;47(6):637-43.
85. Pasmantier R, Chaiken RL, Hirsch SR, Lebovitz HE. Metabolic effects of combination glipizide and human proinsulin treatment in NIDDM. Diabetes Care 1990;13 Suppl 3:42-46.
86. Peacock I, Tattersall RB. The difficult choice of treatment for poorly controlled maturity onset diabetes: tablets or insulin?. British Medical Journal Clinical Research Ed 1984;288(6435):1956-59.
87. Polo V, Saibene A, Pontiroli AE. Nicotinamide improves insulin secretin and metabolic control in lean type 2 diabetic patients with secondary failure to sulphonylureas. Acta Diabetologica 1998;35(1):61-64. [MEDLINE: 3679]
88. Ponssen HH, Elte JW, Lehert P, Schouten JP, Bets D. Combined metformin and insulin therapy for patients with type 2 diabetes mellitus. Clinical Therapeutics 2000;22(6):709-18.
89. Quatraro A, Consoli G, Ceriello A, Giugliano D. Combined insulin and sulfonylurea therapy in non-insulin-dependent diabetics with secondary failure to oral drugs: a one year follow-up. Diabete et Metabolisme 1986;12(6):315-18.
90. Raskin P, Rendell M, Riddle MC, Dole JF, Freed MI, Rosenstock J. A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes Care 2001;24(7):1226-32.
91. Reich A, Abraira C, Lawrence AM. Combined glyburide and insulin therapy in type II diabetes. Diabetes Research 1987;6(2):99-104.
92. Relimpio F, Pumar A, Losada F, Mangas MA, Acosta D, Astorga R. Adding metformin versus insulin dose increase in insulin-treated but poorly controlled Type 2 diabetes mellitus: an open-label randomized trial. Diabetic Medicine 1998;15(12):997-1002.
93. Rivellese AA, Patti L, Romano G, Innelli F, Di Marino L, Annuzzi G, et al. Effect of insulin and sulfonylurea therapy, at the same level of blood glucose control, on low density lipoprotein subfractions in type 2 diabetic patients. Journal of Clinical Endocrinology & Metabolism 2000;85(11):4188-92.
94. Robinson AC, Burke J, Robinson S, Johnston DG, Elkeles RS. The effects of metformin on glycemic control and serum lipids in insulin-treated NIDDM patients with suboptimal metabolic control. Diabetes Care 1998;21(5):701-5. [MEDLINE: 3683]
95. Rodier M. Effects of insulin therapy upon plasma lipid fatty acids and platelet aggregation in NIDDM with secondary failure to oral antidiabetic agents. Diabetes Research and Clinical Practice 1995;28(1):19-28.
96. Romano G, Patti L, Innelli F, Di Marino L, Annuzzi G, Iavicoli M, et al. Insulin and sulfonylurea therapy in NIDDM patients. Are the effects on lipoprotein metabolism different even with similar blood glucose control?. Diabetes 1997;46:1601-6.
97. Rosak C, Schwarz O, Althoff PH, Schoffling K, Schmidt FH. [Combined treatment of type-2 diabetics with insulin and glibenclamide after secondary drug failure. Double-blind, insulin-placebo-controlled crossover study]. [German]. Deutsche Medizinische Wochenschrift 1985;110(51-52):1975-80.
98. Samanta A, Burden AC, Kinghorn HA. A comparative study of sulphonylurea and insulin therapy in non insulin dependent diabetics who had failed on diet therapy alone. Diabetes Research 1987;4:183-5.
99. Sanchez-Barba Izquierdo MI, Ibarra Rueda JM, Ruiz de Adana PR. [The combination of insulin and metformin in obese patients with type-2 diabetes mellitus]. [Spanish]. Atencion Primaria 1999;24(8):462-67.
100. Sane T, Helve E, Yki-Järvinen H, Taskinen MR. One-year response to evening insulin therapy in non-insulin- dependent diabetes. Journal of Internal Medicine 1992;231:253-60. [MEDLINE: 4839]
101. Sangiorgio L, Rabuazzo MA, Cordaro G, Grasso G, Condorelli L, Lunetta M. [Comparative study of the efficiency of ultralente insulin and NPH insulin combined with sulfonylurea in type 2 diabetes patients with secondary tolerance to sulfonylurea. Possible selection criteria]. Minerva Endocrinol 1996;21(2):47-52. [MEDLINE: 3681]
102. Schade DS, Mitchell WJ, Griego G. Addition of sulfonylurea to insulin treatment in poorly controlled type II diabetes. A double-blind, randomized clinical trial. JAMA 1987;257(18):2441-45.
103. Schwartz SL, Fischer JS, Kipnes MS, Boyle M. Effects of short-term insulin therapy upon therapeutic response to glipizide. American Journal of Medicine 1987;83(3A):22-30.
104. Schwartz S, Raskin P, Fonseca V, Graveline JF. Effect of troglitazone in insulin-treated patients with type II diabetes mellitus. Troglitazone and Exogenous Insulin Study Group. [see comments]. New England Journal of Medicine 1998;338(13):861-66.
105. Simonson DC, Delprato S, Castellino P, Groop L, DeFronzo RA. Effect of glyburide on glycemic control, insulin requirement, and glucose metabolism in insulin-treated diabetic patients. Diabetes 1987;36(2):136-46.
106. Simpson HC, Sturley R, Stirling CA, Reckless JP. Combination of insulin with glipizide increases peripheral glucose disposal in secondary failure type 2 diabetic patients. Diabetic Medicine 1990;7(2):143-47.
107. Sinagra D, Scarpitta AM, Amato M. Effects of insulin-oral hypoglycemic agents combined therapy in outpatients with type 2 diabetes. European Review for Medical & Pharmacological Sciences 1998;2(5-6):175-79.
108. Soneru IL, Agrawal L, Murphy JC, Lawrence AM, Abraira C. Comparison of morning or bedtime insulin with and without glyburide in secondary sulfonylurea failure. Diabetes Care 1993;16(6):896-901.
109. Sotaniemi EA, Vierimaa E, Huupponen R, Karvonen I, Vuoti MJ, Rytomaa K. Insulin and sulphonylurea in the therapy of type 2 diabetes. Diabetes Research and Clinical practice 1990;8:243-51.
110. Standl E, Baumgartl HJ, Fuchtenbusch M, Stemplinger J. Effect of acarbose on additional insulin therapy in type 2 diabetic patients with late failure of sulphonylurea therapy. Diabetes Obesity & Metabolism 1999;1(4):215-20.
111. Stenman S, Groop PH, Saloranta C, Totterman KJ, Fyhrqvist F, Groop L. Effects of the combination of insulin and glibenclamide in type 2 (non-insulin-dependent) diabetic patients with secondary failure to oral hypoglycaemic agents. Diabetologia 1988;31(4):206-13.
112. Stocks AE MAH. Lack of effect of glibenclamide on insulin requirements and diabetic control in persons with insulin-dependent diabetes. Medical Journal of Australia 1988;149(9):472-73.
113. Stradner F, Pieber T, Toplak H, Schreiber U, Pfeiffer KP. [Insulin-sulfonylurea combination therapy in secondary therapy failure with sulfonylurea compounds. Randomized study between evening and morning intermediary insulin administration using the Novo Pen semi- automatic insulin injector]. Schweizerische medizinische Wochenschrift 1990;120(27-28):989-94. [MEDLINE: 4250]
114. Thompson RG, Pearson L, Schoenfeld SL, Kolterman OG. Pramlintide, a synthetic analog of human amylin, improves the metabolic profile of patients with type 2 diabetes using insulin. The Pramlintide in Type 2 Diabetes Group. Diabetes Care 1998;21(6):987-93.
115. Tovi J, Ingemansson SO, Engfeldt P. Insulin treatment of elderly type 2 diabetic patients: effects on retinopathy. Diabetes & Metabolism 1998;24(5):442-47.
116. Trischitta V, Italia S, Mazzarino S, Buscema M, Rabuazzo AM, Sangiorgio, L, et al. Comparison of combined therapies in treatment of secondary failure to glyburide. Diabetes Care 1992;15(4):539-42.
117. Trischitta V, Italia S, Raimondo M, Guardabasso V, Licciardello C, Runello F, et al. Efficacy of combined treatments in NIDDM patients with secondary failure to sulphonylureas. Is it predictable?. Journal of Endocrinological Investigation 1998;21(11):744-47.
118. Trznadel-Morawska I, Malecki M, Sieradzki J. [Estimation of different models of insulin therapy in noninsulin-dependent diabetes mellitus]. Przeglad lekarski 1997;54(5):308-13. [MEDLINE: 3680]
119. Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA 1999;281(21):2005-12.
120. United Kingdom Prospective Diabetes Study (UKPDS). 13: Relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years. [see comments]. BMJ 1995;310(6972):83-88.
121. 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. United Kingdom Prospective Diabetes Study Group. [see comments]. Annals of Internal Medicine 1998;128(3):165-75.
122. 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. [see comments]. [erratum appears in Lancet 1999 Aug 14;354(9178):602]. Lancet 1998;352(9131):837-53.
123. Vigneri R, Trischitta V, Italia S, Mazzarino S, Rabuazzo MA, Squatrito, S. Treatment of NIDDM patients with secondary failure to glyburide: comparison of the addition of either metformin or bed-time NPH insulin to glyburide. Diabete et Metabolisme 1991;17(1 Pt 2):232-34.
124. Wolffenbuttel BH, Weber RF, van Koetsveld PM, Weeks L, Verschoor L. A randomized crossover study of sulphonylurea and insulin treatment in patients with type 2 diabetes poorly controlled on dietary therapy. Diabetic Medicine 1989;6:520-25.
125. Yki-Jarvinen H, Dressler A, Ziemen M, HOE 901/300s Study, Group. 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. HOE 901/3002 Study Group. Diabetes Care 2000;23(8):1130-36.
126. Yu JG, Kruszynska YT, Mulford MI, Olefsky JM. A comparison of troglitazone and metformin on insulin requirements in euglycemic intensively insulin-treated type 2 diabetic patients. Diabetes 1999;48(12):2414-21.
127. Yudkin JS, Panahloo A, Stehouwer C, Emeis JJ, Bulmer K, Mohamed-Ali V, Denver AE. The influence of improved glycaemic control with insulin and sulphonylureas on acute phase and endothelial markers in Type II diabetic subjects. Diabetologia 2000;43(9):1099-1106.
128. Goudswaard AN, Stolk RP, Zuithoff P, de Valk HW, Rutten GE. Starting insulin in type 2 diabetes: Continue oral hypoglycemic agents? A randomized trial in primary care. Journal of Family Practice 2004;53(5):393-399.
129. Olsson PO, Lindstrom T. Combination-therapy with bedtime nph insulin and sulphonylureas gives similar glycaemic control but lower weight gain than insulin twice daily in patients with type 2 diabetes. Diabetes Metab 2002;28(4 Pt 1):272-277.
130. Stehouwer MH, DeVries JH, Lumeij JA, Ader HJ, Engbers AM, Iperen AA, Snoek FJ, Heine RJ. 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(2):148-152.
131. American Diabetic Association. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 1997;20:1183-97.
132. The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 1999;22(Suppl 1):S5-19.
133. Agurs Collins TD, Kumanyika SK, Ten Have TR, Adams Campbell LL. A randomized controlled tria of weight reduction and exercise for diabetes management in older African-American subjects. Diabetes Care 1997;20(10):1503-11.
134. Armitage P, Berry G, Matthews JNS. Statistical methods in medical research, par. 5.3. 4th Edition. Blackwell Science, 2002:paragraph 5.3.
135. Bosello O, Armellini F, Zamboni M, Fitchet M. The benefits of modest weight loss in type II diabetes. International Journal of Obesity and related Metabolic disorders 1997;21 Suppl 1:S10-3.
136. Burgers JS, Bailey JV, Klazinga NS, van der Bij AK, Grol R, Feder G. Inside guidelines: comparative analysis of recommendations and evidence in diabetes guidelines from 13 countries. Diabetes Care 2002;25(11):1933-39.
137. Cohen J. A coefficient of agreement for nominal scales. Educational and psychological measurement 1960;20:37-46.
138. 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. The New England journal of medicine 1993;329:977-86.
139. Sonnaville de JJ, Snoek FJ, Colly LP, Deville W, Wijkel D, Heine RJ. Well-being and symptoms in relation to insulin therapy in type 2 diabetes. Diabetes Care 1998;21(6):919-24.
140. DerSimonian R, Laird N. Meta-analysis in clinical trials. Controlled clinical trials 1986;7(3):177-88. [MEDLINE: 28]
141. Egger M, Davey SG, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315(7109):629-34.
142. Garber AJ. Benefits of combination therapy of insulin and oral hypoglycemic agents. Archives of internal medicine 2003;163(15):1781-82.
143. Goddijn PP, Bilo HJ, Feskens EJ, Groenier KH, van der Zee KI, Meyboom-de Jong B. Longitudinal study on glycaemic control and quality of life in patients with Type 2 diabetes mellitus referred for intensified control. Diabetic Medicine 1999;16(1):23-30.
144. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327(7414):557-60.
145. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary?. Controlled Clinical Trials 1996;17:1-12.
146. Johnson JL, Wolf SL, Kabadi UM. Efficacy of insulin and sulfonylurea combination therapy in type II diabetes. A meta-analysis of the randomized placebo-controlled trials. Archives of internal medicine 1996;156(3):259-64.
147. Lau J, Loannidis JPA, Schmid CH. Quantitative synthesis in systematic reviews. Annals of internal medicine 1997;127:820-6.
148. Little RR, England JD, Wiedmeyer HM, McKenzie EM, Mitra R, Erhart PM, Durham JB, Goldstein DE. Interlaboratory standardization of glycated hemoglobin determinations. Clinical chemistry 1986;32(2):358-60.
149. Mulrow CD, Oxman AD. Cochrane Collaboration Handbook. updated September 1997. Vol. 4, Oxford: Update Software, 1997.
150. National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes 1979;28:1039-57.
151. Peters AL, Davidson MB. Insulin plus a sulfonylurea agent for treating type 2 diabetes. Annals of internal medicine 1991;115(1):45-53.
152. Pugh-JA, Wagner-ML, Sawyer-J, Ramirez-G, Tuley-M, Friedberg-SJ. Is combination sulfonylurea and insulin therapy useful in NIDDM patients? A metaanalysis [see comments]. Diabetes Care 1992;15:953-9.
153. Riddle MC. Timely addition of insulin to oral therapy for type 2 diabetes. Diabetes Care 2002;25(2):395-96.
154. 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(11):3080-86.
155. Rosenthal R. Parametric measures of effect size. In: Cooper H, Hedges HV editor(s). The handbook of research synthesis. New York: Sage Foundation, 1994:231-44.
156. Ruige JB, Assendelft WJ, Dekker JM, Kostense PJ, Heine RJ, Bouter LM. Insulin and risk of cardiovascular disease: a meta-analysis. Circulation 1998;97(10):996-1001.
157. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Journal of the American Medical Association 1995;273:408-12.
158. Stout RW. Insulin and atheroma. 20-yr perspective. Diabetes Care 1990;13(6):631-54.
159. Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA 1999;281(21):2005-12.
160. 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.
161. Does van der FE, De Neeling JN, Snoek FJ, Kostense PJ, Grootenhuis PA, Bouter LM, Heine RJ. Symptoms and well-being in relation to glycemic control in type II diabetes. Diabetes Care 1996;19(3):204-10.
162. Van Tulder MW, Assendelft WJJ, Koes BW, Bouter LM. Method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group for Spinal Disorders. Spine 1997;22:2323-30.
163. Westphal SA, Palumbo PJ. Insulin and oral hypoglycemic agents should not be used in combination in the treatment of type 2 diabetes. Archives of internal medicine 2003;163(15):1783-85.
164. WHO Expert Committee on Diabetes Mellitus. Second report. Technical Report Series 646. Geneva. WHO, 1980.
165. WHO Expert Committee on Diabetes Mellitus. World Health Organization, 1985. Technical Report Series 727.
166. World Health Organization. Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications. Report of a WHO Consultation. Part 1: Diagnosis and Classification of Diabetes Mellitus. Geneva: World Health Organization, 1999:1-59. [MEDLINE: 179]
167. Yki-Järvinen 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. HOE 901/3002 Study Group. Diabetes Care 2000;23(8):1130-36.
168. Yki-Järvinen H. Combination therapies with insulin in type 2 diabetes. Diabetes Care 2001;24(4):758-67.
169. Zavaroni I, Bonora E, Pagliara M, Dall'Aglio E, Luchetti L, Buonanno G, et al. Risk factors for coronary artery disease in healthy persons with hyperinsulinemia and normal glucose tolerance. The New England Journal of Medicine 1989;320(11):702-6.