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The effect of the availability of inhaled insulin on glycaemic control in patients with Type 2 diabetes failing on oral therapy: the evaluation of Exubera® as a therapeutic option on insulin initiation and improvement in glycaemic control in clinical practice (EXPERIENCE) trial
Author(s) -
Del Prato S.,
Blonde L.,
Martinez L.,
Göke B.,
Woo V.,
Millward A.,
Gomis R.,
Canovatchel B.,
Strack T.,
Lawrence D.,
Freemantle N.
Publication year - 2008
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2008.02438.x
Subject(s) - medicine , odds ratio , insulin , randomized controlled trial , clinical endpoint , type 2 diabetes , confidence interval , regimen , diabetes mellitus , endocrinology
Aim To examine the impact of inhaled human insulin (Exubera®, EXU) on patient or physician willingness to adopt insulin after oral glucose‐lowering agent failure. Methods During a randomized controlled trial in primary, secondary and tertiary care in Europe and North America, 739 patients using ≥ 2 oral glucose‐lowering agents with glycated haemoglobin (HbA 1c ) ≥ 8.0% were assigned to two treatment groups: Group 1 (standard care with the option of EXU) or Group 2 (standard care only). Standard care included adjusting oral therapy (optimizing current regimen or adding/omitting agents) and/or initiating subcutaneous (s.c.) insulin. The primary endpoint was difference in HbA 1c between randomized groups at 26 weeks. Secondary outcomes included differences in the rate of uptake of insulin therapy, proportion achieving satisfactory glycaemic control, treatment satisfaction and safety outcomes. Results At baseline, insulin was initiated by more [odds ratio 6.0; 95% confidence interval (CI) 4.2 to 8.8; P < 0.0001] patients in Group 1 (86.2%; 76.7% EXU plus 9.5% s.c.) than Group 2 (50.7%; s.c. insulin only). At 26 weeks, mean ( sd ) changes in HbA 1c from baseline were –2.0% (1.2%) and –1.7% (1.3%) in Groups 1 and 2, respectively, a difference of –0.2% (95% CI: –0.1% to –0.4%; P = 0.004). In Group 1, 45% of patients achieved an HbA 1c ≤ 7.0% by 26 weeks compared with 39% in Group 2 ( P = 0.02). Conclusion The availability of EXU may increase initiation of insulin, thereby contributing to improved overall glycaemic control in patients with Type 2 diabetes inadequately controlled on two or more oral glucose‐lowering agents.