Treat-to-target trials in diabetes

Indian Journal of Endocrinology and Metabolism

Volumn 18, Issue 2, 2014, Pages 166-174

  Wangnoo, Subhash K ^a   Sethi, Bipin ^b   Sahay, Rakesh K ^c   John, Mathew ^d   Ghosal, Samit ^e   Sharma, Surendra K ^f  

^a INDRAPRASTHA APOLLO HOSPITAL   (India)

^b CARE HOSPITAL   (India)

^c OSMANIA MEDICAL COLLEGE   (India)

^d Providence Endocrine and Diabetes Specialty Centre   (India)

^e Nightingale Hospital   (India)

^f Dr SK Sharma's Diabetes Thyroid and Endocrine Centre   (India)

Author keywords

Clinical trials; diabetes; efficacy; safety

Indexed keywords

EID: 84995422403     PISSN: 22308210     EISSN: 22309500     Source Type: Journal    
DOI: 10.4103/2230-8210.129106     Document Type: Review

References (50)

1. Castrejón I, Pincus T. Differences in treat-To-Target in patients with rheumatoid arthritis versus hypertension and diabetes-consequences for clinical care. Bull NYU Hosp Jt Dis 2011;69:104-10.
2. Atar D, Birkeland KI, Uhlig T. Treat to target: moving targets from hypertension, hyperlipidaemia and diabetes to rheumatoid arthritis. Ann Rheum Dis 2010;69:629-30.
3. American Diabetes Association. Standards of medical care in diabetes-2012. Diabetes Care 2012;35:S11-63.
4. Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA, et al. AACE Task Force for Developing Diabetes Comprehensive Care Plan. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract 2011;17:1-53.
5. Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren M, et al. European Association for Cardiovascular Prevention and Rehabilitation (EACPR); ESC Committee for Practice Guidelines (CPG). European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J 2012;33:1635-701.
6. Graham I, Atar D, Borch-Johnsen K, Boysen G, Burell G, Cifkova R, et al. European Society of Cardiology (ESC); European Association for Cardiovascular Prevention and Rehabilitation (EACPR); Council on Cardiovascular Nursing; European Association for Study of Diabetes (EASD); International Diabetes Federation Europe (IDF-Europe); European Stroke Initiative (EUSI); Society of Behavioural Medicine (ISBM); European Society of Hypertension (ESH); WONCA Europe (European Society of General Practice/Family Medicine); European Heart Network (EHN); European Atherosclerosis Society (EAS). European guidelines on cardiovascular disease prevention in clinical practice: full text. Fourth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts). Eur J Cardiovasc Prev Rehabil 2007;14:S1-13.
7. Felson DT. Choosing a core set of disease activity measures for rheumatoid arthritis clinical trials. J Rheumatol 1993;20:531-4.
8. Serra-Bonett N, Rodríguez MA. The swollen joint, the thickened artery, and the smoking gun: Tobacco exposure, citrullination and rheumatoid arthritis. Rheumatol Int 2011;31:567-72.
9. 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. N Engl J Med 1993;329:977-86.
10. National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes 1979;28:1039-57.
11. 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 1997;20:1183-97.
12. 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;26:3080-6.
13. Riddle MC. The Treat-To-Target Trial and related studies. Endocr Pract 2006;12:71-9.
14. 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.
15. Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM, et al. Tests of glycemia in diabetes. Diabetes Care 2004;27:1761-73.
16. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364-79.
17. Rodbard HW, Jellinger PS. Comment on: Inzucchi et al. Management of hyperglycemia in type 2 diabetes: A patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364-79. Diabetes Care 2012;35:e70; author replye72-3.
18. Rydén L, Standl E, Bartnik M, Van den Berghe G, Betteridge J, de Boer MJ, et al. Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC); European Association for the Study of Diabetes (EASD). Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD). Eur Heart J 2007;28:88-136.
19. Hermansen K, Mortensen LS, Hermansen ML. Combining insulins with oral antidiabetic agents: Effect on hyperglycemic control, markers of cardiovascular risk and disease. Vasc Health Risk Manag 2008;4:561-74.
20. Riddle MC. Starting and advancing insulin for type 2 diabetes: Algorithms and individualized methods are both necessary. J Clin Endocrinol Metab 2008;93:372-4.
21. Farmer AJ, Oke J, Stevens R, Holman RR. Differences in insulin treatment satisfaction following randomized addition of biphasic, prandial or basal insulin to oral therapy in type 2 diabetes. Diabetes Obes Metab 2011;13:1136-41.
22. Davies M, Lavalle-González F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: Results from the AT.LANTUS trial. Diabetes Obes Metab 2008;10:387-99.
23. Lundby Christensen L, Almdal T, Boesgaard T, Breum L, Dunn E, Gade-Rasmussen B, et al. CIMT Trial Group. Study rationale and design of the CIMT trial: The Copenhagen Insulin and Metformin Therapy trial. Diabetes Obes Metab 2009;11:315-22.
24. Ardigò D, Vaccaro O, Cavalot F, Rivellese AA, Franzini L, Miccoli R, et al. Effectiveness of treat-To-Target strategy for LDL-cholesterol control in type 2 diabetes Post-hoc analysis of data from the MIND.IT study. Eur J Prev Cardiol 2012. [In press]
25. 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 2diabetes. HOE 901/3002 Study Group. Diabetes Care 2000;23:1130-6.
26. Strange P. Treat-To-Target insulin titration algorithms when initiating long or intermediate acting insulin in type 2 diabetes. J Diabetes Sci Technol 2007;1:540-8.
27. Tanenberg R, Zisman A, Stewart J. Glycemia optimization treatment (GOT): Glycemic control and rate of severe hypoglycemia for five different dosing algorithms of insulin glargine (GLAR) in patients with type 2 diabetes mellitus (T2DM). 66 th Sci Sess Am Diabetes Assoc (ADA), Washington, DC (Jun 2006), Abstr. 567-P. Diabetes 2006;55:A135.
28. Meneghini L, Schwartz S, Soltes Rak E, Harris A, Strange P. Improved glycemic control with insulin glargine vs pioglitazone as add-on therapy in patients with type 2 diabetes uncontrolled on sulfonylurea or metformin monotherapy. Late breaking abstract 10 poster at the ADA annual meeting; 2005.
29. Hollander P, Sugimoto D, Kilo C, Harris A, Vlajnic A. Combination therapy with insulin glargine plus metformin but not glargine plus sulfonylurea provides similar glycemic control to triple oral combination in patients with type 2 diabetes failing dual oral agents. Late breaking abstract 9 poster at the ADA annual meeting; 2005.
30. Holman RR, Turner RC. A practical guide to basal and prandial insulin therapy. Diabet Med 1985;2:45-53.
31. 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;138:952-9.
32. Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; AT.LANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: Comparison of two treatment algorithms using insulin glargine. Diabetes Care 2005;28:1282-8.
33. 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;11:623-31.
34. Brunton S, Gough S, Hicks D, Weng J, Moghissi E, Peyrot M, et al. A look into the future: Improving diabetes care by 2015. Curr Med Res Opin 2011;27:65-72.
35. Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, et al.; 4-T Study Group. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007;357:1716-30.
36. Freemantle N, Meneghini L, Christensen T, Wolden ML, Jendle J, Ratner R, et al. Insulin degludec improves health-related quality of life (SF-36(®) compared with insulin glargine in people with Type 2 diabetes starting on basal insulin: A meta-Analysis of phase 3a trials. Diabet Med 2013;30:226-32.
37. Fonseca VA. Ongoing clinical trials evaluating the cardiovascular safety and efficacy of therapeutic approaches to diabetes mellitus. Am J Cardiol 2011;108:52B-8.
38. Zinman B, Philis-Tsimikas A, Cariou B, Handelsman Y, Rodbard HW, Johansen T, et al. NN1250-3579 (BEGIN Once Long) Trial Investigators. Insulin degludec versus insulin glargine in insulin-naive patients with type 2 diabetes: A 1-year, randomized, treat-To-Target trial (BEGIN Once Long). Diabetes Care 2012;35:2464-71.
39. Heller S, Buse J, Fisher M, Garg S, Marre M, Merker L, et al. BEGIN Basal-Bolus Type 1 Trial Investigators. Insulin degludec, an ultra-long acting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-To-Target non-inferiority trial. Lancet 2012;379:1489-97.
40. Garber AJ, King AB, Del Prato S, Sreenan S, Balci MK, Muñoz-Torres M, et al. NN1250-3582 (BEGIN BB T2D) Trial Investigators. Insulin degludec, an ultra-long acting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): A phase 3, randomised, open-label, treat-To-Target non-inferiority trial. Lancet 2012;379:1498-507.
41. Swinnen SG, Dain MP, Aronson R, Davies M, Gerstein HC, Pfeiffer AF, et al. A 24-week, randomized, treat-To-Target trial comparing initiation of insulin glargine once-daily with insulin detemir twice-daily in patients with type 2 diabetes inadequately controlled on oral glucose-lowering drugs. Diabetes Care 2010;33:1176-8.
42. Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-To-Target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naïve people with type 2 diabetes. Diabetologia 2008;51:408-16.
43. Heise T, Tack CJ, Cuddihy R, Davidson J, Gouet D, Liebl A, et al. A new-generation ultra-long-Acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: A randomized, controlled trial. Diabetes Care 2011;34:669-74.
44. Raskin P, Gylvin T, Weng W, Chaykin L. Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes. Diabetes Metab Res Rev 2009;25:542-8.
45. Hollander P, Cooper J, Bregnhøj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-To-Target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther 2008;30:1976-87.
46. Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B; PREFER Study Group. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: A randomized controlled trial. Diabetes Obes Metab 2009;11:45-52.
47. Carey M, Khunti K, Davies M. Structured education in diabetes: A review of the evidence. Diabetes Prim Care 2012;14:154-62.
48. Crasto W, Jarvis J, Khunti K, Skinner TC, Gray LJ, Brela J, et al. Multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: The Microalbuminuria Education and Medication Optimisation (MEMO) study. Diabetes Res Clin Pract 2011;93:328-36.
49. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study. BMJ 2000;321:405-12.
50. Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006;28:1569-81.