Preferred Treatment of Type 1.5 Diabetes

Summary

The purpose of this research was to test whether one treatment was superior over another in the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide.

Timeline

Start

2000-02

Primary completion

2008-09

Completion

2008-12

Publications

• Background Lampeter EF, Homberg M, Quabeck K, Schaefer UW, Wernet P, Bertrams J, Grosse-Wilde H, Gries FA, Kolb H. Transfer of insulin-dependent diabetes between HLA-identical siblings by bone marrow transplantation. Lancet. 1993 May 15;341(8855):1243-4. doi: 10.1016/0140-6736(93)91148-f.
• Background DeFronzo RA. Pathogenesis of type 2 (non-insulin dependent) diabetes mellitus: a balanced overview. Diabetologia. 1992 Apr;35(4):389-97. doi: 10.1007/BF00401208. No abstract available.
• Background Porte D Jr. Banting lecture 1990. Beta-cells in type II diabetes mellitus. Diabetes. 1991 Feb;40(2):166-80. doi: 10.2337/diab.40.2.166.
• Background Zimmet PZ, Tuomi T, Mackay IR, Rowley MJ, Knowles W, Cohen M, Lang DA. Latent autoimmune diabetes mellitus in adults (LADA): the role of antibodies to glutamic acid decarboxylase in diagnosis and prediction of insulin dependency. Diabet Med. 1994 Apr;11(3):299-303. doi: 10.1111/j.1464-5491.1994.tb00275.x.
• Background Tuomi T, Groop LC, Zimmet PZ, Rowley MJ, Knowles W, Mackay IR. Antibodies to glutamic acid decarboxylase reveal latent autoimmune diabetes mellitus in adults with a non-insulin-dependent onset of disease. Diabetes. 1993 Feb;42(2):359-62. doi: 10.2337/diab.42.2.359.
• Background Zimmet PZ. The pathogenesis and prevention of diabetes in adults. Genes, autoimmunity, and demography. Diabetes Care. 1995 Jul;18(7):1050-64. doi: 10.2337/diacare.18.7.1050. No abstract available.
• Background Groop LC, Bottazzo GF, Doniach D. Islet cell antibodies identify latent type I diabetes in patients aged 35-75 years at diagnosis. Diabetes. 1986 Feb;35(2):237-41. doi: 10.2337/diab.35.2.237.
• Background Groop L, Miettinen A, Groop PH, Meri S, Koskimies S, Bottazzo GF. Organ-specific autoimmunity and HLA-DR antigens as markers for beta-cell destruction in patients with type II diabetes. Diabetes. 1988 Jan;37(1):99-103. doi: 10.2337/diab.37.1.99.
• Background Kobayashi T, Tamemoto K, Nakanishi K, Kato N, Okubo M, Kajio H, Sugimoto T, Murase T, Kosaka K. Immunogenetic and clinical characterization of slowly progressive IDDM. Diabetes Care. 1993 May;16(5):780-8. doi: 10.2337/diacare.16.5.780.
• Background Kobayashi T. Subtype of insulin-dependent diabetes mellitus (IDDM) in Japan: slowly progressive IDDM--the clinical characteristics and pathogenesis of the syndrome. Diabetes Res Clin Pract. 1994 Oct;24 Suppl:S95-9. doi: 10.1016/0168-8227(94)90234-8.
• Background Kobayashi T, Nakanishi K, Sugimoto T, Itoh T, Murase T, Kosaka K, Tsuji K. Maleness as risk factor for slowly progressive IDDM. Diabetes Care. 1989 Jan;12(1):7-11. doi: 10.2337/diacare.12.1.7.
• Background Kobayashi T, Itoh T, Kosaka K, Sato K, Tsuji K. Time course of islet cell antibodies and beta-cell function in non-insulin-dependent stage of type I diabetes. Diabetes. 1987 Apr;36(4):510-7. doi: 10.2337/diab.36.4.510.
• Background Nakanishi K, Kobayashi T, Sugimoto T, Murase T, Itoh T, Kosaka K. Predictive value of insulin autoantibodies for further progression of beta cell dysfunction in non-insulin-dependent diabetics. Diabetes Res. 1988 Nov;9(3):105-9.
• Background Hao W, Li L, Mehta V, Lernmark A, Palmer JP. Functional state of the beta cell affects expression of both forms of glutamic acid decarboxylase. Pancreas. 1994 Sep;9(5):558-62. doi: 10.1097/00006676-199409000-00003.
• Background Mehta V, Hao W, Brooks-Worrell BM, Palmer JP. The functional state of the beta cell modulates IL-1 and TNF-induced cytotoxicity. Lymphokine Cytokine Res. 1993 Aug;12(4):255-9.
• Background Gotfredsen CF, Buschard K, Frandsen EK. Reduction of diabetes incidence of BB Wistar rats by early prophylactic insulin treatment of diabetes-prone animals. Diabetologia. 1985 Dec;28(12):933-5. doi: 10.1007/BF00703140.
• Background Atkinson MA, Maclaren NK, Luchetta R. Insulitis and diabetes in NOD mice reduced by prophylactic insulin therapy. Diabetes. 1990 Aug;39(8):933-7. doi: 10.2337/diab.39.8.933.
• Background Keller RJ, Eisenbarth GS, Jackson RA. Insulin prophylaxis in individuals at high risk of type I diabetes. Lancet. 1993 Apr 10;341(8850):927-8. doi: 10.1016/0140-6736(93)91215-8.
• Background Effect of intensive therapy on residual beta-cell function in patients with type 1 diabetes in the diabetes control and complications trial. A randomized, controlled trial. The Diabetes Control and Complications Trial Research Group. Ann Intern Med. 1998 Apr 1;128(7):517-23. doi: 10.7326/0003-4819-128-7-199804010-00001.
• Background Diabetes Prevention Trial--Type 1 Diabetes Study Group. Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med. 2002 May 30;346(22):1685-91. doi: 10.1056/NEJMoa012350.
• Background Kobayashi T, Nakanishi K, Murase T, Kosaka K. Small doses of subcutaneous insulin as a strategy for preventing slowly progressive beta-cell failure in islet cell antibody-positive patients with clinical features of NIDDM. Diabetes. 1996 May;45(5):622-6. doi: 10.2337/diab.45.5.622.
• Background Kobayashi T, Maruyama T, Shimada A, Kasuga A, Kanatsuka A, Takei I, Tanaka S, Yokoyama J. Insulin intervention to preserve beta cells in slowly progressive insulin-dependent (type 1) diabetes mellitus. Ann N Y Acad Sci. 2002 Apr;958:117-30. doi: 10.1111/j.1749-6632.2002.tb02954.x.
• Background Kumar S, Boulton AJ, Beck-Nielsen H, Berthezene F, Muggeo M, Persson B, Spinas GA, Donoghue S, Lettis S, Stewart-Long P. Troglitazone, an insulin action enhancer, improves metabolic control in NIDDM patients. Troglitazone Study Group. Diabetologia. 1996 Jun;39(6):701-9. doi: 10.1007/BF00418542.
• Background Antonucci T, Whitcomb R, McLain R, Lockwood D, Norris RM. Impaired glucose tolerance is normalized by treatment with the thiazolidinedione troglitazone. Diabetes Care. 1997 Feb;20(2):188-93. doi: 10.2337/diacare.20.2.188.
• Background Nolan JJ, Ludvik B, Beerdsen P, Joyce M, Olefsky J. Improvement in glucose tolerance and insulin resistance in obese subjects treated with troglitazone. N Engl J Med. 1994 Nov 3;331(18):1188-93. doi: 10.1056/NEJM199411033311803.
• Background Nakanishi K, Kobayashi T, Miyashita H, Ohkubo M, Sugimoto T, Murase T, Kosaka K, Inouye K, Kono M. Relationships among islet cell antibodies, residual beta-cell function, and metabolic control in patients with insulin-dependent diabetes mellitus of long duration: use of a sensitive C-peptide radioimmunoassay. Metabolism. 1990 Sep;39(9):925-30. doi: 10.1016/0026-0495(90)90302-s.
• Background Nakanishi K, Kobayashi T, Inoko H, Tsuji K, Murase T, Kosaka K. Residual beta-cell function and HLA-A24 in IDDM. Markers of glycemic control and subsequent development of diabetic retinopathy. Diabetes. 1995 Nov;44(11):1334-9. doi: 10.2337/diab.44.11.1334.
• Background Sjoberg S, Gunnarsson R, Gjotterberg M, Lefvert AK, Persson A, Ostman J. Residual insulin production, glycaemic control and prevalence of microvascular lesions and polyneuropathy in long-term type 1 (insulin-dependent) diabetes mellitus. Diabetologia. 1987 Apr;30(4):208-13. doi: 10.1007/BF00270417.
• Background Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
• Background Juneja R, Hirsch IB, Naik RG, Brooks-Worrell BM, Greenbaum CJ, Palmer JP. Islet cell antibodies and glutamic acid decarboxylase antibodies, but not the clinical phenotype, help to identify type 1(1/2) diabetes in patients presenting with type 2 diabetes. Metabolism. 2001 Sep;50(9):1008-13. doi: 10.1053/meta.2001.25654.
• Background Brooks-Worrell BM, Juneja R, Minokadeh A, Greenbaum CJ, Palmer JP. Cellular immune responses to human islet proteins in antibody-positive type 2 diabetic patients. Diabetes. 1999 May;48(5):983-8. doi: 10.2337/diabetes.48.5.983.
• Background Gleichmann H, Zorcher B, Greulich B, Gries FA, Henrichs HR, Betrams J, Kolb H. Correlation of islet cell antibodies and HLA-DR phenotypes with diabetes mellitus in adults. Diabetologia. 1984 Jul;27 Suppl:90-2. doi: 10.1007/BF00275656.
• Background Hagopian WA, Karlsen AE, Gottsater A, Landin-Olsson M, Grubin CE, Sundkvist G, Petersen JS, Boel E, Dyrberg T, Lernmark A. Quantitative assay using recombinant human islet glutamic acid decarboxylase (GAD65) shows that 64K autoantibody positivity at onset predicts diabetes type. J Clin Invest. 1993 Jan;91(1):368-74. doi: 10.1172/JCI116195.
• Background Rowley MJ, Mackay IR, Chen QY, Knowles WJ, Zimmet PZ. Antibodies to glutamic acid decarboxylase discriminate major types of diabetes mellitus. Diabetes. 1992 Apr;41(4):548-51. doi: 10.2337/diab.41.4.548.
• Brooks-Worrell BM, Palmer JP. Attenuation of islet-specific T cell responses is associated with C-peptide improvement in autoimmune type 2 diabetes patients. Clin Exp Immunol. 2013 Feb;171(2):164-70. doi: 10.1111/cei.12012.

Drugs

Indications