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（旧版）科学的根拠に基づく糖尿病診療ガイドライン 改訂第2版
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6．インスリンによる治療
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| 1） | Early worsening of diabetic retinopathy in the Diabetes Control and Complications Trial. Arch Ophthalmol. 1998;116(7):874-86. レベル1 |
| 2） | 高橋良当，高山真一郎，伊藤威之，井上幸子，大森安恵．糖尿病における治療後有痛性神経障害86例の病態．糖尿病．1998;41(3):165-70. レベル4 |
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| 4） | The effect of intensive diabetes therapy on measures of autonomic nervous system function in the Diabetes Control and Complications Trial (DCCT). Diabetologia. 1998;41(4):416-23. レベル1 |
| 5） | Lawson ML, Gerstein HC, Tsui E, Zinman B. Effect of intensive therapy on early macrovascular disease in young individuals with type 1 diabetes. A systematic review and meta-analysis. Diabetes Care. 1999;22 Suppl 2:B35-9. レベル1＋ |
| 6） | Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353(25):2643-53. レベル1 |
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| 10） | 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. Ann Intern Med. 1998;128(3):165-75. レベル1 |
| 11） | Feinglos MN, Thacker CR, Lobaugh B, DeAtkine DD, McNeill DB, English JS, Bursey DL. Combination insulin and sulfonylurea therapy in insulin-requiring type 2 diabetes mellitus. Diabetes Res Clin Pract. 1998;39(3):193-9. レベル2－ |
| 12） | Wright A, Burden AC, Paisey RB, Cull CA, Holman RR; U.K. Prospective Diabetes Study Group. Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57). Diabetes Care. 2002;25(2):330-6. レベル1 |
| 13） | Avilés-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. Ann Intern Med. 1999;131(3):182-8. レベル2－ |
| 14） | 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. Diabet Med. 1998;15(12):997-1002. レベル2－ |
| 15） | Yki-Järvinen H, Ryysy L, Nikkilä K, Tulokas T, Vanamo R, Heikkilä M. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial. Ann Intern Med. 1999;130(5):389-96. レベル2 |
| 16） | Ponssen HH, Elte JW, Lehert P, Schouten JP, Bets D. Combined metformin and insulin therapy for patients with type 2 diabetes mellitus. Clin Ther. 2000;22(6):709-18. レベル2－ |
| 17） | Kelley DE, Bidot P, Freedman Z, Haag B, Podlecki D, Rendell M, Schimel D, Weiss S, Taylor T, Krol A, Magner J. Efficacy and safety of acarbose in insulin-treated patients with type 2 diabetes. Diabetes Care. 1998;21(12):2056-61. レベル2 |
| 18） | Juntti-Berggren L, Pigon J, Hellström P, Holst JJ, Efendic S. Influence of acarbose on post-prandial insulin requirements in patients with Type 1 diabetes. Diabetes Nutr Metab. 2000;13(1):7-12. レベル2－ |
| 19） | Buse JB, Gumbiner B, Mathias NP, Nelson DM, Faja BW, Whitcomb RW. Troglitazone use in insulin-treated type 2 diabetic patients. The Troglitazone Insulin Study Group. Diabetes Care. 1998;21(9):1455-61. レベル2 |
| 20） | 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. N Engl J Med. 1998;338(13):861-6. レベル2 |
| 21） | 小坂樹徳，豊田隆謙，葛谷 健，赤沼安夫，繁田幸男，兼子俊男，七里元亮．インスリン依存或いはインスリン非依存糖尿病患者に対する経口血糖降下薬CS-045のインスリンとの併用投与における臨床評価 プラセボを対照薬とした二重盲検比較試験．医学のあゆみ．1996;179(12-3):951-79. レベル2 |
| 22） | Raskin P, Rendell M, Riddle MC, Dole JF, Freed MI, Rosenstock J; Rosiglitazone Clinical Trials Study Group. A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. Diabetes Care. 2001;24(7):1226-32. レベル2 |
| 23） | 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):1052-7. レベル2 |
| 24） | Shank ML, Del Prato S, DeFronzo RA. Bedtime insulin/daytime glipizide. Effective therapy for sulfonylurea failures in NIDDM. Diabetes. 1995;44(2):165-72. レベル2－ |
| 25） | Trischitta V, Italia S, Raimondo M, Guardabasso V, Licciardello C, Runello F, Mazzarino S, Sangiorgi L, Anello M, Vigneri R. Efficacy of combined treatments in NIDDM patients with secondary failure to sulphonylureas. Is it predictable? J Endocrinol Invest. 1998;21(11):744-7. レベル2－ |
| 26） | Home PD, Lindholm A, Riis A; European Insulin Aspart Study Group. Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabet Med. 2000;17(11):762-70. レベル1 |
| 27） | Gale EA. A randomized, controlled trial comparing insulin lispro with human soluble insulin in patients with Type 1 diabetes on intensified insulin therapy. The UK Trial Group. Diabet Med. 2000;17(3):209-14. レベル2 |
| 28） | 葛谷 健，小坂樹徳，赤沼安夫，繁田幸男，豊田隆謙，堀田 饒，七里元亮，河盛隆造，岩本安彦，大橋靖雄．1型及び2型糖尿病患者の頻回注射療法におけるインスリンリスプロと速効型ヒトインスリン製剤の比較 本邦における臨床試験成績．臨床医薬．2000;16(11):1613-30. レベル2－ |
| 29） | 岩本安彦，赤沼安夫，新美仁男，佐々木望，田嶼尚子，河盛隆造，繁田幸男．Basal-Bolus療法を実施中の1型糖尿病(IDDM)患者におけるインスリンアスパルトと速効型ヒトインスリンの比較 国内第III相臨床試験成績．糖尿病．2001;44(10):799-811. レベル2－ |
| 30） | Raskin P, Holcombe JH, Tamborlane WV, Malone JI, Strowig S, Ahern JA, Lavent F. A comparison of insulin lispro and buffered regular human insulin administered via continuous subcutaneous insulin infusion pump. J Diabetes Complications. 2001;15(6):295-300. レベル2 |
| 31） | Bode BW, Strange P. Efficacy, safety, and pump compatibility of insulin aspart used in continuous subcutaneous insulin infusion therapy in patients with type 1 diabetes. Diabetes Care. 2001;24(1):69-72. レベル2－ |
| 32） | Roach P, Trautmann M, Arora V, Sun B, Anderson JH Jr. Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel insulin lispro-protamine formulations, insulin lispro mix25 and insulin lispro mix50. Mix50 Study Group. Clin Ther. 1999;21(3):523-34. レベル2－ |
| 33） | Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002;19(5):393-9. レベル2－ |
| 34） | 岩本安彦，河盛隆造，門脇 孝，赤沼安夫．インスリン治療を必要とする糖尿病患者を対象としたリスプロ混合製剤-25及びリスプロ混合製剤-50の1日2回投与による一般臨床試験．臨床医薬．2002;18(3)395-409. レベル4 |
| 35） | 岩本安彦，赤沼安夫．2型糖尿病患者における二相性インスリンアスパルト-30のヒトインスリン混合製剤を対照薬とした48週間比較試験 国内第III相臨床試験成績．臨床医薬．2003;19(8):891-904. レベル2－ |
| 36） | Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA. Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. U.S. Study Group of Insulin Glargine in Type 1 Diabetes. Diabetes Care. 2000;23(5):639-43. レベル2－ |
| 37） | Rossetti P, Pampanelli S, Fanelli C, Porcellati F, Costa E, Torlone E, Scionti L, Bolli GB. Intensive replacement of basal insulin in patients with type 1 diabetes given rapid-acting insulin analog at mealtime: a 3-month comparison between administration of NPH insulin four times daily and glargine insulin at dinner or bedtime. Diabetes Care. 2003;26(5):1490-6. レベル2－ |
| 38） | Yki-Järvinen 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):1130-6. レベル2－ |
| 39） | Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. 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):3080-6. レベル2－ |
