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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

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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 1530-891X

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Abstract

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
ISSN: 1530-891X
Official Date: 6 September 2011
Volume: Vol.17
Number: No.5
Page Range: pp. 727-736
Identification Number: 10.4158/EP10367.OR
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Restricted or Subscription Access
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URI: http://wrap.warwick.ac.uk/id/eprint/34670

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