A comparison of two intensification regimens with rapid-acting insulin aspart in type 2 diabetes inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs : the STEP-Wise™ randomized study
Meneghini, Luigi, Mersebach, Henriette, Kumar, Sudhesh, Svendsen, Anne Louise and Hermansen, Kjeld. (2011) A comparison of two intensification regimens with rapid-acting insulin aspart in type 2 diabetes inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs : the STEP-Wise™ randomized study. Endocrine Practice, Vol.17 (No.5). pp. 727-736. ISSN 1530-891XFull text not available from this repository.
Official URL: http://dx.doi.org/10.4158/EP10367.OR
Objective: Comparison of the efficacy and safety of two intensification strategies for stepwise addition of prandial insulin aspart (IAsp) in patients with type 2 diabetes treated with insulin detemir (IDet).
Methods: This was a randomized, controlled, parallel-group, open-label, 48-week trial comparing stepwise addition of IAsp to either the largest meal (titration based on pre-meal glucose values ‘SimpleSTEP’) or to the meal with the largest prandial glucose increment (titration based on post-meal values ‘ExtraSTEP’) in 296 individuals inadequately controlled on basal insulin and oral antidiabetes drugs (OADs). Following 12 weeks of basal IDet dose optimization, participants with HbA1c ≥7% entered three 12-week treatment periods with stepwise addition of a first IAsp bolus, then a second, and then a third, if HbA1c remained ≥7% after 12 and 24 weeks of treatment, respectively. Endpoints included HbA1c (primary endpoint), fasting plasma glucose (FPG), self-measured plasma glucose (SMPG), adverse events and hypoglycemia.
Results: HbA1c decreased by ~1.2% in both groups, to 7.5±1.1% (SimpleSTEP) and 7.7±1.2% (ExtraSTEP) at end-of-trial (estimated treatment difference, SimpleSTEP - ExtraSTEP: -0.06%, (95%CI: -0.29 to 0.17)). SMPG levels decreased with both regimens. At trial end, approximately 75% of patients in each group were using three prandial injections. The frequency of adverse events and hypoglycemia was low, and similar between groups.
Conclusion: The SimpleSTEP and ExtraSTEP strategies for stepwise addition of IAsp to one or more meals were equally effective at intensifying therapy in patients with type 2 diabetes not achieving glycemic control on basal insulin and OADs.
|Item Type:||Journal Article|
|Subjects:||R Medicine > RC Internal medicine|
|Divisions:||Faculty of Medicine > Warwick Medical School|
|Journal or Publication Title:||Endocrine Practice|
|Publisher:||American Association of Clinical Endocrinologists|
|Official Date:||6 September 2011|
|Page Range:||pp. 727-736|
|Access rights to Published version:||Restricted or Subscription Access|
UK Prospective Diabetes Study. V. Characteristics of newly presenting type 2 diabetic patients: estimated insulin sensitivity and islet β-cell function. Multi-centre study. Diabet Med. 1988;5:444-448.
Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. New Engl J Med. 2008;359:1577-1589.
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.
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;28:1569-1581.
Blonde L, Merilainen M, Karwe V, Raskin P; TIRATE Study Group. Patient-directed titration of 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.
Holman RR, Thorne KI, Farmer AJ, 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;357:1716-1730.
Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomized, 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. Diabetolog. 2008;51:408-416.
Raccah D, Bretzel RG, Owens D, Riddle M. When basal insulin therapy in type 2 diabetes mellitus is not enough - what next? Diabetes Metab Res Rev. 2007;23:257-264.
Hirsch IB, Yuan H, Campaigne BN, Tan MH. Impact of prandial plus basal vs basal insulin on glycemic variability in type 2 diabetic patients. Endocr Pract. 2009;15:343-348.
Gerich JE. Clinical significance, pathogenesis, and management of postprandial hyperglycemia. Arch Intern Med. 2003;163:1306-1316.
Gerich JE, Odawara M, Terauchi Y. The rationale for paired pre- and postprandial self-monitoring of blood glucose: the role of glycemic variability in micro- and macrovascular risk. Curr Med Res Opin. 2007;23:1791-1798.
Halbron M, Jacqueminet S, Sachon C, Bosquet F, Hartemann-Heurtier A, Grimaldi A. Insulin therapy for type 2 diabetes: premixed or basal-prandial? Diab & Metab. 2007;33:316-320.
Jang HC, Guler S, Shestakova M, PRESENT Study Group. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. Int J Clin Pract. 2008;62:1013-1018.
Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetolog. 2008;31:20-25.
Lankisch MR, Ferlinz KC, Leahy JL, Scherbaum WA, Oral Plus Apidra and LANTUS (OPAL) study group. Introducing a simplified approach to insulin therapy in type 2 diabetes: a comparison of two single-dose regimens of insulin glulisine plus insulin glargine and oral antidiabetic drugs. Diabetes Obes Metab. 2008;10:1178-1185.
World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and last amended by the 59th WMA General Assembly, Seoul, October 2008.
International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1), Step 4. 1996.
Bergenstal RM, Johnson M, Powers MA, et al. Adjust to target in type 2 diabetes: comparison of a simple algorithm with carbohydrate counting for adjustment of mealtime insulin glulisine. Diabetes Care. 2008;31:1305-1310.
Hermansen K, Mortensen LS. Bodyweight changes associated with antihyperglycaemic agents in type 2 diabetes mellitus. Drug Saf. 2007;30:1127-1142.
Fajardo Montañana C, Hernández Herrero C, Rivas Fernández M. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008;25:916-923.
Monami M, Marchionni N, Mannucci E. Long-acting insulin analogues versus NPH human insulin in type 2 diabetes: a meta-analysis. Diabetes Res Clin Pract. 2008;81:184-189.
Actions (login required)