Treat-to-target trials: Uses, interpretation and review of concepts

Diabetes, Obesity and Metabolism

Volumn 16, Issue 3, 2014, Pages 193-205

  Garber, A J ^a  

^a BAYLOR COLLEGE OF MEDICINE   (United States)

Author keywords

Insulin aspart; Insulin degludec; Insulin detemir; Insulin glargine; Neutral protamine Hagedorn (NPH); Treat to target trials; Type 2 diabetes

Indexed keywords

HEMOGLOBIN A1C; INSULIN ASPART; INSULIN DEGLUDEC; INSULIN DETEMIR; INSULIN GLARGINE; ISOPHANE INSULIN;

ALGORITHM; BLOOD PRESSURE; BODY WEIGHT; CARDIOVASCULAR RISK; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); COST EFFECTIVENESS ANALYSIS; DIABETES CONTROL; DIET RESTRICTION; DRUG DOSE TITRATION; DRUG EFFICACY; FOOD AND DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INJECTION SITE REACTION; INSULIN TREATMENT; INTENTION TO TREAT ANALYSIS; MULTICENTER STUDY (TOPIC); NON INFERIORITY TRIAL; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT COMPLIANCE; POSTPRANDIAL STATE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK BENEFIT ANALYSIS; TREAT TO TARGET TRIAL; TREATMENT OUTCOME; WEIGHT GAIN;

INSULIN ASPART; INSULIN DEGLUDEC; INSULIN DETEMIR; INSULIN GLARGINE; NEUTRAL PROTAMINE HAGEDORN (NPH); TREAT-TO-TARGET TRIALS; TYPE 2 DIABETES;

BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN ASPART; INSULIN, LONG-ACTING; MALE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 84893788399     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12129     Document Type: Review

References (47)

1. US Food and Drug Administration. 2008. Center for Drug Evaluation and Research. Guidance for Industry. Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071624.pdf. Accessed 14 June 2011.
2. 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). JAMA 1999; 281: 2005-2012.
3. Palumbo PJ. The case for insulin treatment early in type 2 diabetes. Cleve Clin J Med 2004; 71: 394.
4. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 2011; 365: 2002-2012.
5. 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: 540-548.
6. 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: 3080-3086.
7. Riddle M, Hart J, Bingham P, Garrison C, McDaniel P. Combined therapy for obese type 2 diabetes: suppertime mixed insulin with daytime sulfonylurea. Am J Med Sci 1992; 303: 151-156.
8. Yki-Jarvinen H, Dressler A, Ziemen M, The HOE 901/3002 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. Diabetes Care 2000; 23: 1130-1136.
9. Schwartz S, Sievers R, Strange P, Lyness WH, Hollander P. Insulin 70/30 mix plus metformin versus triple oral therapy in the treatment of type 2 diabetes after failure of two oral drugs: efficacy, safety, and cost analysis. Diabetes Care 2003; 26: 2238-2243.
10. 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: 1052-1057.
11. UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837-853.
12. UK Prospective Diabetes Study Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352: 854-865.
13. Diabetes Control and Complications Trial Research Group. 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; 329: 977-986.
14. Rudolf P, Bartelme A. A strategic action plan for achieving uncompromising "treat to target" in individuals with insulin-dependent diabetes: a report by the Center for Insulin-Dependent Diabetes Access' Blue Ribbon Panel. Diabetes Technol Ther 2005; 7: 755-767.
15. Phillips LS, Branch WT, Cook CB et al. Clinical inertia. Ann Intern Med 2001; 135: 825-834.
16. Atar D, Birkeland KI, Uhlig T. 'Treat to target': moving targets from hypertension, hyperlipidaemia and diabetes to rheumatoid arthritis. Ann Rheum Dis 2010; 69: 629-630.
17. 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: 542-548.
18. Hollander P, Cooper J, Bregnhoj 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: 1976-1987.
19. Philis-Tsimikas A. An update on the use of insulin detemir, with a focus on type 2 diabetes (drug evaluation update). Expert Opin Pharmacother 2008; 9: 2181-2195.
20. Sitbon O, Galie N. Treat-to-target strategies in pulmonary arterial hypertension: the importance of using multiple goals. Eur Respir Rev 2010; 19: 272-278.
21. Blonde L, Merilainen M, Karwe V, Raskin P. 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.
22. Guler S, Vaz JA, Ligthelm R. Intensification lessons with modern premixes: from clinical trial to clinical practice. Diabetes Res Clin Pract 2008; 81(Suppl 2): S23-30.
23. Hermansen K, Davies M, Derezinski T, Ravn GM, 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.
24. Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B. 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.
25. Fogelfeld L, Dharmalingamt M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med 2010; 27: 181-188.
26. Fonseca V, Davidson J, Home P et al. Starting insulin therapy with basal insulin analog or premix insulin analog in T2DM: a pooled analysis of treat-to-target trials. Curr Med Res Opin 2010; 26: 1621-1628.
27. Holman RR, Thorne KI, Farmer AJ et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007; 357: 1716-1730.
28. 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.
29. Dailey G, Strange P, Riddle M. Reconsideration of Severe Hypoglycemic Events in the Treat-to-Target Trial. Diabetes Technol Ther 2009; 11: 477-479.
30. Brunton S. Implementing treatment guidelines for type 2 diabetes in primary care. Postgrad Med 2009; 121: 125-138.
31. Brunton S. Beyond glycemic control: treating the entire type 2 diabetes disorder. Postgrad Med 2009; 121: 68-81.
32. Swinnen SG, Snoek FJ, Dain MP, Devries JH, Hoekstra JB, Holleman F. Rationale, design, and baseline data of the insulin glargine (Lantus) versus insulin detemir (Levemir) treat-to-target (L2T3) study: a multinational, randomized noninferiority trial of basal insulin initiation in type 2 diabetes. Diabetes Technol Ther 2009; 11: 739-743.
33. 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-naive people with type 2 diabetes. Diabetologia 2008; 51: 408-416.
34. Garber AJ, King AB, Francisco A, Endahl LA, Hollander PA. Insulin degludec improves long-term glycemic control with less nocturnal hypoglycemia compared with insulin glargine: 1-year results from a randomized basal-bolus trial in people with type 2 diabetes. Diabetes 2011; 60(Suppl 1): A20.
35. Heller S, Francisco AM, Pei H, Russell-Jones D. Insulin degludec improves long-term glycemic control with less nocturnal hypoglycemia compared with insulin glargine: 1-year results from a randomized basal-bolus trial in type 1 diabetes. Diabetes 2011; 60(Suppl 1): A19.
36. Malone JK, Kerr LF, Campaigne BN, Sachson RA, Holcombe JH. Combined therapy with insulin lispro Mix 75/25 plus metformin or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with type 2 diabetes beginning insulin therapy. Clin Ther 2004; 26: 2034-2044.
37. Janka HU, Plewe G, Riddle MC, Kliebe-Frisch C, Schweitzer MA, Yki-Jarvinen H. Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 2005; 28: 254-259.
38. Malone JK, Bai S, Campaigne BN, Reviriego J, Augendre-Ferrante B. Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with type 2 diabetes. Diabet Med 2005; 22: 374-381.
39. Raskin P, Allen E, Hollander P et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care 2005; 28: 260-265.
40. Garber AJ, Wahlen J, Wahl T et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (the 1-2-3 study). Diabetes Obes Metab 2006; 8: 58-66.
41. Yang W, Ji Q, Zhu D et al. Biphasic insulin aspart 30 three times daily is more effective than a twice-daily regimen, without increasing hypoglycemia, in Chinese subjects with type 2 diabetes inadequately controlled on OADs. Diabetes Care 2008; 31: 852-856.
42. Strojek K, Bebakar WM, Khutsoane DT et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin 2009; 25: 2887-2894.
43. Swinnen SG, Dain MP, Aronson R 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: 1176-1178.
44. Rosenstock J, Lorber DL, Gnudi L et al. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. Lancet 2010; 375: 2244-2253.
45. Dailey G, Rosenstock J, Moses RG, Ways K. Insulin glulisine provides improved glycemic control in patients with type 2 diabetes. Diabetes Care 2004; 27: 2363-2368.
46. Yki-Jarvinen H, Kauppinen-Makelin R, Tiikkainen M et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia 2006; 49: 442-451.
47. Birkeland KI, Home PD, Wendisch U et al. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care 2011; 34: 661-665.