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 |
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| Institution: | 1. Division of Endocrinology, Diabetes, and Metabolism, University of Miami Miller School of Medicine, Miami, Florida;;2. Novo Nordisk, Global Development, Soeborg, Denmark;3. University of Warwick, Unit for Diabetes and Metabolism, Warwick Medical School, Clinical Sciences Research Institute, Coventry, United Kingdom;4. Department of Endocrinology and Metabolism, MEA, Aarhus University Hospital, Aarhus, Denmark.;1. Molecular Metabolism, Lund University Diabetes Centre, Malmö, Sweden;2. Neuroendocrine Cell Biology, Lund University Diabetes Centre, Malmö Sweden;3. Aleris Obesitas, Lund, Sweden;4. Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden;2. GRECC, MERCE, Baltimore, Maryland;3. Department of Neurology, University of Maryland School of Medicine, Baltimore, Maryland |
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| Abstract: | ObjectiveTo 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.MethodsThis 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 A1 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 A1c remained at 7% or greater after 12 and 24 weeks of treatment, respectively. Endpoints included hemoglobin A1c (primary endpoint), fasting plasma glucose, self-measured plasma glucose, adverse events, and hypoglycemia.ResultsTwo hundred ninety-six patients were randomly assigned to treatment with insulin aspart in the SimpleSTEP (n = 150) and ExtraSTEP (n = 146) groups. Hemoglobin A1c decreased by approximately 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% 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.ConclusionThe 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. (Endocr Pract. 2011;17:727-736) |
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