Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: The step-wise randomized study

Luigi Meneghini, Henriette Mersebach, Sudhesh Kumar, Anne Louise Svendsen, Kjeld Hermansen

Research output: Contribution to journalArticle

59 Scopus citations


Objective: To compare the efficacy and safety of 2 intensification strategies for stepwise addition of prandial insulin aspart in patients with type 2 diabetes mellitus treated with insulin detemir. Methods: This randomized, controlled, parallel-group, open-label, 48-week trial compared the stepwise addition of insulin aspart to either the largest meal (titration based on premeal glucose values [SimpleSTEP]) or to the meal with the largest prandial glucose increment (titration based on postmeal glucose values [ExtraSTEP]) in patients with type 2 diabetes inadequately controlled on basal insulin and oral antidiabetes drugs. After 12 weeks of basal insulin detemir dosage optimization, participants with a hemoglobin A 1c level of 7% or greater entered three 12-week treatment periods with stepwise addition of a first insulin aspart bolus, then a second, and then a third, if hemoglobin A 1c remained at 7% or greater after 12 and 24 weeks of treatment, respectively. Endpoints included hemoglobin A 1c (primary endpoint), fasting plasma glucose, self-measured plasma glucose, adverse events, and hypoglycemia. Results: Two hundred ninety-six patients were randomly assigned to treatment with insulin aspart in the SimpleSTEP (n = 150) and ExtraSTEP (n = 146) groups. Hemoglobin A 1c decreased by approximately 1.2% in both groups, to 7.5 ± 1.1% (Simple-STEP) and 7.7 ± 1.2% (ExtraSTEP) at end of trial (estimated treatment difference, SimpleSTEP - ExtraSTEP: -0.06% [95% confidence interval, -0.29 to 0.17]). Self-measured plasma glucose levels decreased with both regimens. At trial end, approximately 75% of patients in each group were using 3 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 insulin aspart to 1 or more meals were equally effective at intensifying therapy in patients with type 2 diabetes not achieving glycemic control on basal insulin and oral antidiabetic drugs.

Original languageEnglish (US)
Pages (from-to)727-736
Number of pages10
JournalEndocrine Practice
Issue number5
StatePublished - Sep 1 2011


ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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