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 (HbA1c) ≥ 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 HbA1c 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 HbA1c 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 HbA1c≤ 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.