Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study): a randomised, treat-to-target clinical trial
| Autor: | Line Conradsen Hiort, Henning F. Andersen, Helena W. Rodbard, Virginia E. Visco, David H.W. Shu |
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| Rok vydání: | 2014 |
| Předmět: |
Blood Glucose
Male medicine.medical_specialty Diabetes Mellitus Type 2/drug therapy Glycated Hemoglobin A/metabolism Endocrinology Diabetes and Metabolism Type 2 diabetes Hypoglycemia Rate ratio Drug Administration Schedule Hypoglycemia/complications law.invention Insulin aspart Endocrinology Randomized controlled trial law Internal medicine Diabetes mellitus Internal Medicine medicine Hypoglycemic Agents Humans Insulin Aspart/administration & dosage Meals Insulin Aspart Aged Glycated Hemoglobin business.industry Middle Aged Hypoglycemic Agents/administration & dosage medicine.disease Surgery Clinical trial Regimen Diabetes Mellitus Type 2 Female business medicine.drug |
| Zdroj: | Rodbard, H W, Visco, V E, Andersen, H, Hiort, L C & Shu, D H W 2014, ' Treatment intensification with stepwise addition of prandial insulin aspart boluses compared with full basal-bolus therapy (FullSTEP Study) : a randomised, treat-to-target clinical trial ', The Lancet Diabetes & Endocrinology, vol. 2, no. 1, pp. 30-7 . https://doi.org/10.1016/S2213-8587(13)70090-1 |
| ISSN: | 2213-8587 |
| Popis: | BACKGROUND: We compared stepwise addition of bolus insulin with a full basal-bolus regimen in patients with type 2 diabetes inadequately controlled on basal insulin plus oral antidiabetic drugs.METHODS: The FullSTEP study was a phase 4, 32-week, randomised, open-label, two-arm, parallel-group, multinational, treat-to-target, non-inferiority trial done at 150 sites across seven countries to assess the effectiveness of a stepwise dosing approach versus a basal-bolus regimen. In this trial, 401 patients (mean age 59·8 years [SD 9·3]; HbA1c 7·9% [63 mmol/mol]; mean diabetes duration 12·6 years [SD 8·0]) were block randomised (ratio 1:1) to receive either stepwise treatment or full basal-bolus treatment. Patients in the basal-bolus group received insulin aspart before every meal throughout the trial. Patients in the stepwise group received one bolus dose with the largest meal, with additional insulin aspart doses before the next largest meal added to their regimen at 11 weeks and 22 weeks if HbA1c remained at 7% or higher. The primary outcome was non-inferiority of stepwise addition of bolus insulin versus complete basal-bolus therapy, as assessed by change in HbA1c from baseline to 32 weeks (non-inferiority margin of 0·4%). This trial is registered with ClinicalTrials.gov, number NCT01165684.FINDINGS: The study was started on Oct 27, 2010, and completed on April 25, 2012. After 32 weeks, HbA1c change from baseline was -0·98% (95% CI -1·09 to -0·87) for the stepwise group and -1·12% (-1·23 to -1·00) for the basal-bolus group; mean treatment difference 0·14 (95% CI -0·02 to 0·30), non-significant (p=0·0876). Fewer hypoglycaemic episodes occurred in the stepwise group than in the basal-bolus group (rate ratio 0·58 [95% CI 0·45 to 0·75]; pINTERPRETATION: Stepwise prandial insulin intensification provides glycaemic control non-inferior to a full basal-bolus regimen after 32 weeks, with significantly lower hypoglycaemia risk and better patient satisfaction.FUNDING: Novo Nordisk. |
| Databáze: | OpenAIRE |
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