9. Pharmacologic approaches to glycemic treatment: Standards of medical care in diabetesd2019

Diabetes Care

Volumn 42, Issue , 2019, Pages S90-S102

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

BLOOD; DIABETES MELLITUS; DRUG EFFECT; GLUCOSE BLOOD LEVEL; HEALTH CARE QUALITY; HUMAN; MEDICAL SOCIETY; PRACTICE GUIDELINE; UNITED STATES;

BLOOD GLUCOSE; DIABETES MELLITUS; GLYCATED HEMOGLOBIN A; HUMANS; HYPOGLYCEMIC AGENTS; PRACTICE GUIDELINES AS TOPIC; SOCIETIES, MEDICAL; STANDARD OF CARE; UNITED STATES;

EID: 85058738504     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc19-S009     Document Type: Article

References (87)

1. Peters A, Laffel L (Eds.). American Diabetes Association/JDRF Type 1 Diabetes Sourcebook. Alexandria, VA, American Diabetes Association, 2013
2. Chiang JL, Kirkman MS, Laffel LMB, Peters AL; Type 1 Diabetes Sourcebook Authors. Type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes Care 2014;37:2034–2054
3. Wolpert HA, Atakov-Castillo A, Smith SA, Steil GM. Dietary fat acutely increases glucose concentrations and insulin requirements in patients with type 1 diabetes: implications for carbohydrate-based bolus dose calculation and intensive diabetes management. Diabetes Care 2013;36:810–816
4. Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized mealtime insulin dosing for fat and protein in type 1 diabetes: application of a model-based approach to derive insulin doses for open-loop diabetes management. Diabetes Care 2016; 39:1631–1634
5. Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care 2015;38:1008–1015
6. Yeh H-C, Brown TT, Maruthur N, et al. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med 2012;157:336–347
7. Pickup JC. The evidence base for diabetes technology: appropriate and inappropriate meta-analysis. J Diabetes Sci Technol 2013;7:1567–1574
8. Bergenstal RM, Klonoff DC, Garg SK, et al.; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med 2013;369:224–232
9. Buckingham BA, Raghinaru D, Cameron F, et al.; In Home Closed Loop Study Group. Predictive low-glucose insulin suspension reduces duration of nocturnal hypoglycemia in children without increasing ketosis. Diabetes Care 2015; 38:1197–1204
10. Bergenstal RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA 2016;316:1407–1408
11. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther 2017;19:155–163
12. Cleary PA, Orchard TJ, Genuth S, etal.;DCCT/ EDIC Research Group. The effect of intensive glycemic treatment on coronary artery calcification in type 1 diabetic participants of the Diabetes Control and Complications Trial/ Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. Diabetes 2006;55:3556–3565
13. Nathan DM, Cleary PA, Backlund J-YC, et al.; 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;353:2643–2653
14. Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) Study Research Group. Mortality in type 1 diabetes in the DCCT/EDIC
15. versus the general population. Diabetes Care 2016;39:1378–1383
16. Tricco AC, Ashoor HM, Antony J, et al. Safety, effectiveness, and cost effectiveness of long acting versus intermediate acting insulin for patients with type 1 diabetes: systematic review and network meta-analysis. BMJ 2014;349: g5459
17. Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med 2008;25:442–449
18. DeWitt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. JAMA 2003;289:2254–2264
19. Lane W, Bailey TS, Gerety G, et al.; Group Information; SWITCH 1. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: the SWITCH 1 randomized clinical trial. JAMA 2017;318:33–44
20. Home PD, Bergenstal RM, Bolli GB, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care 2015;38:2217–2225
21. Bode BW, McGill JB, Lorber DL, Gross JL, Chang PC, Bregman DB; Affinity 1 Study Group. Inhaled technosphere insulin compared with injected prandial insulin in type 1 diabetes: a randomized 24-week trial. Diabetes Care 2015;38:2266–2273
22. Frid AH, Kreugel G, Grassi G, et al. New insulin delivery recommendations. Mayo Clin Proc 2016;91:1231–1255
23. Karges B, Boehm BO, Karges W. Early hypoglycaemia after accidental intramuscular injection of insulin glargine. Diabet Med 2005;22: 1444–1445
24. Frid A, Gunnarsson R, Güntner P, Linde B. Effects of accidental intramuscular injection on insulin absorption in IDDM. Diabetes Care 1988; 11:41–45
25. Gibney MA, Arce CH, Byron KJ, Hirsch LJ. Skin and subcutaneous adipose layer thickness in adults with diabetes at sites used for insulin injections: implications for needle length recommendations. Curr Med Res Opin 2010;26:1519–1530
26. Hirsch LJ, Gibney MA, Albanese J, et al. Comparative glycemic control, safety and patient ratings for a new 4 mm 3 32G insulin pen needle in adults with diabetes. Curr Med Res Opin 2010;26:1531–1541
27. Miwa T, Itoh R, Kobayashi T, et al. Comparison of the effects of a new 32-gauge 3 4-mm pen needle and a 32-gauge 3 6-mm pen needle on glycemic control, safety, and patient ratings in Japanese adults with diabetes. Diabetes Technol Ther 2012;14:1084–1090
28. Bergenstal RM, Strock ES, Peremislov D, Gibney MA, Parvu V, Hirsch LJ. Safety and efficacy of insulin therapy delivered via a 4mm pen needle in obese patients with diabetes. Mayo Clin Proc 2015;90:329–338
29. Famulla S, Hövelmann U, Fischer A, et al. Insulin injection into lipohypertrophic tissue: blunted and more variable insulin absorption and action and impaired postprandial glucose control. Diabetes Care 2016;39:1486–1492
30. Ratner RE, Dickey R, Fineman M, et al. Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in type 1 diabetes mellitus: a 1-year, randomized controlled trial. Diabet Med 2004;21:1204–1212
31. Edelman S, Garg S, Frias J, et al. A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. Diabetes Care 2006; 29:2189–2195
32. Meng H, Zhang A, Liang Y, Hao J, Zhang X, Lu J. Effect of metformin on glycaemic control in patients with type 1 diabetes: a meta-analysis of randomized controlled trials. Diabetes Metab Res Rev 2018;34:e2983
33. Petrie JR, Chaturvedi N, Ford I, et al.; REMOVAL Study Group. Cardiovascular and metabolic effects of metformin in patients with type 1 diabetes (REMOVAL): a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol 2017;5:597–609
34. Wang W, Liu H, Xiao S, Liu S, Li X, Yu P. Effects of insulin plus glucagon-like peptide-1 receptor agonists (GLP-1RAs) in treating type 1 diabetes mellitus: a systematic review and meta-analysis. Diabetes Ther 2017;8:727–738
35. Henry RR, Thakkar P, Tong C, Polidori D, Alba M. Efficacy and safety of canagliflozin, a sodium–glucose cotransporter 2 inhibitor, as add-on to insulin in patients with type 1 diabetes. Diabetes Care 2015;38:2258–2265
36. Dandona P, Mathieu C, Phillip M, et al.; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol 2017;5:864–876
37. Patoulias D, Imprialos K, Stavropoulos K, Athyros V, Doumas M. SGLT-2 inhibitors in type 1 diabetes mellitus: a comprehensive review of the literature. Curr Clin Pharmacol. 7 August 2018 [Epub ahead of print]. DOI: 10.2174/ 1574884713666180807150509
38. TM (sotagliflozin) as potential treatment for type 1 diabetes [Internet], 2018. Available from http://www.lexpharma.com/media-center/news/673-fda-to-review-zynquista-sotagliflozin-as-potential-treatment-for-type-1-diabetes. Accessed 30 September 2018
39. Robertson RP, Davis C, Larsen J, Stratta R, Sutherland DER; American Diabetes Association. Pancreas and islet transplantation in type 1 diabetes. Diabetes Care 2006;29:935
40. Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2018;41:2669–2701
41. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577–1589
42. Maruthur NM, Tseng E, Hutfless S, et al. Diabetes medications as monotherapy or metformin-based combination therapy for type 2 diabetes: a systematic review and meta-analysis. Ann Intern Med 2016;164:740–751
43. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function [Internet]. Available from http://www.fda.gov/Drugs/DrugSafety/ucm493244.htm. Accessed 14 October 2016
44. Out M, Kooy A, Lehert P, Schalkwijk CA, Stehouwer CDA. Long-term treatment with metformin in type 2 diabetes and methylmalonic acid: post hoc analysis of a randomized controlled 4.3 year trial. J Diabetes Complications 2018;32:171–178
45. Aroda VR, Edelstein SL, Goldberg RB, et al.; Diabetes Prevention Program Research Group. Long-term metformin use and vitamin B12 deficiency in the Diabetes Prevention Program Outcomes Study. J Clin Endocrinol Metab 2016; 101:1754–1761
46. Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract 2012;66:446–456
47. Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med 2011;154:602–613
48. Vijan S, Sussman JB, Yudkin JS, Hayward RA. Effect of patients’ risks and preferences on health gains with plasma glucose level lowering in type 2 diabetes mellitus. JAMA Intern Med 2014;174:1227–1234
49. Singh S, Wright EE Jr, Kwan AYM, et al. Glucagon-like peptide-1 receptor agonists compared with basal insulins for the treatment of type 2 diabetes mellitus: a systematic review and meta-analysis. Diabetes Obes Metab 2017; 19:228–238
50. Levin PA, Nguyen H, Wittbrodt ET, Kim SC. Glucagon-like peptide-1 receptor agonists: a systematic review of comparative effectiveness research. Diabetes Metab Syndr Obes 2017; 10:123–139
51. Abd El Aziz MS, Kahle M, Meier JJ, Nauck MA. A meta-analysis comparing clinical effects of short- or long-acting GLP-1 receptor agonists versus insulin treatment from head-to-head studies in type 2 diabetic patients. Diabetes Obes Metab 2017;19:216–227
52. Institute for Clinical and Economic Review. Controversies in the management of patients with type 2 diabetes [Internet], December 2014. Available from https://icer-review.org/wp-content/uploads/2015/03/CEPAC-T2D-Final-Report-December-22.pdf. Accessed 9 November 2018
53. Truven Health Analytics. Micromedex 2.0 Introduction to RED BOOK Online [Internet], 2018. Available from http://www.micromedexsolutions.com/micromedex2/4.34.0/WebHelp/RED_BOOK/ Introduction_to_REDB_BOOK_Online.htm. Accessed 5 September 2018
54. Centers for Medicare & Medicaid Services. NADAC (national average drug acquisition cost), drug pricing and payment [Internet], 2018. Available from https://data.medicaid.gov/Drug-Pricingand-Payment/NADAC-National-Average-Drug-Acquisition-Cost-/a4y5-998d. Accessed 5 September 2018
55. Zinman B,Wanner C, Lachin JM, etal.;EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373: 2117–2128
56. Neal B, Perkovic V, Mahaffey KW, et al.; CANVAS Program Collaborative Group. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 2017;377:644–657
57. Marso SP, Daniels GH, Brown-Frandsen K, et al.; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016;375:311–322
58. Marso SP, Bain SC, Consoli A, et al.; SUSTAIN-6 Investigators. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 2016;375:1834–1844
59. Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets – the TITRATE study. Diabetes Obes Metab 2009;11:623–631
60. Porcellati F, Lucidi P, Cioli P, et al. Pharma-cokinetics and pharmacodynamics of insulin glargine given in the evening as compared with in the morning in type 2 diabetes. Diabetes Care 2015;38:503–512
61. Wang Z, Hedrington MS, Gogitidze Joy N, et al. Dose-response effects of insulin glargine in type 2 diabetes. Diabetes Care 2010;33:1555–1560
62. Singh SR, Ahmad F, Lal A, Yu C, Bai Z, Bennett H. Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis. CMAJ 2009;180:385–397
63. Horvath K, Jeitler K, Berghold A, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007;2: CD005613
64. Monami M, Marchionni N, Mannucci E. Long-actinginsulinanaloguesversusNPHhuman insulin in type 2 diabetes: a meta-analysis. Diabetes Res Clin Pract 2008;81:184–189
65. Owens DR, Traylor L, Mullins P, Landgraf W. Patient-level meta-analysis of efficacy and hypoglycaemia in people with type 2 diabetes initiating insulin glargine 100 U/mL or neutral protamine Hagedorn insulin analysed according to concomitant oral antidiabetes therapy. Diabetes Res Clin Pract 2017;124(Suppl. C):57–65
66. Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or humanNPHinsulintooraltherapyoftype2diabetic patients. Diabetes Care 2003;26:3080–3086
67. Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006;29:1269–1274
68. Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006;49:442–451
69. Bolli GB, Riddle MC, Bergenstal RM, et al.; EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab 2015;17:386–394
70. Terauchi Y, Koyama M, Cheng X, et al. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab 2016;18:366–374
71. Yki-Järvinen H, Bergenstal RM, Bolli GB, et al. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab 2015;17:1142–1149
72. Marso SP, McGuire DK, Zinman B, et al.; DEVOTE Study Group. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med 2017;377:723–732
73. Rodbard HW, Cariou B, Zinman B, et al.; BEGIN Once Long trial investigators. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med 2013;30:1298–1304
74. Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: the SWITCH 2 randomized clinical trial. JAMA 2017;318:45–56
75. Zinman B, Philis-Tsimikas A, Cariou B, et al.; NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: a1-year,randomized,treat-to-targettrial(BEGIN Once Long). Diabetes Care 2012;35:2464–2471
76. Lipska KJ, Parker MM, Moffet HH, Huang ES, Karter AJ. Association of initiation of basal insulin analogs vs neutral protamine Hagedorn insulin with hypoglycemia-related emergency department visits or hospital admissions and with glycemic control in patients with type 2 diabetes. JAMA 2018;320:53–62
77. Cefalu WT, Dawes DE, Gavlak G, etal.;Insulin Access and Affordability Working Group. Insulin Access and Affordability Working Group: conclusions and recommendations. Diabetes Care 2018;41:1299–1311
78. Lipska KJ, Hirsch IB, Riddle MC. Human insulin for type 2 diabetes: an effective, less-expensive option. JAMA 2017;318:23–24
79. Mannucci E, Monami M, Marchionni N. Short-acting insulin analogues vs. regular human insulin in type 2 diabetes: a meta-analysis. Diabetes Obes Metab 2009;11:53–59
80. Heller S, Bode B, Kozlovski P, Svendsen AL. Meta-analysis of insulin aspart versus regular human insulin used in a basal-bolus regimen for the treatment of diabetes mellitus. J Diabetes 2013;5:482–491
81. Riddle MC, Yki-Järvinen H, Bolli GB, et al. One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension. Diabetes Obes Metab 2015;17:835–842
82. Yki-Järvinen H, Bergenstal R, Ziemen M, et al.; EDITION 2 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/ mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care 2014; 37:3235–3243
83. Akturk HK, Snell-Bergeon JK, Rewers A, et al. Improved postprandial glucose with inhaled technosphere insulin compared with insulin aspart in patients with type 1 diabetes on multiple dailyinjections:theSTATstudy.DiabetesTechnol Ther 2018;20:639–647
84. Diamant M, Nauck MA, Shaginian R, etal.;4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulinintype2diabetes.DiabetesCare2014;37: 2763–2773
85. Eng C, Kramer CK, Zinman B, Retnakaran R. Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis. Lancet 2014;384:2228–2234
86. Maiorino MI, Chiodini P, Bellastella G, Capuano A, Esposito K, Giugliano D. Insulin and glucagon-like peptide 1 receptor agonist combination therapy in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Care 2017;40:614–624
87. Rodbard HW, Visco VE, Andersen H, Hiort LC, Shu DHW. Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial. Lancet Diabetes Endocrinol 2014;2:30–37