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An Open, Randomized, Parallel-Group Study to Compare the Efficacy and Safety Profile of Inhaled Human Insulin (Exubera) With Glibenclamide as Adjunctive Therapy in Patients With Type 2 Diabetes Poorly Controlled on Metformin

Response to Kanna and Abreu-Pacheco

¹ University of Birmingham and Heart of England National Health Service Foundation Trust (Teaching), Birmingham, U.K
² Department of Diabetes and Metabolism, Bethanien Krankenhaus, Hamburg, Germany
³ Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark
⁴ Pfizer Ltd., Sandwich, U.K

Address correspondence to A.H. Barnett, Undergraduate Centre, Birmingham Heartlands Hospital, Bordesley Green East, Birmingham, B9 5SS, U.K. E-mail: anthony.barnett{at}heartofengland.nhs.uk

We thank Kanna and Abreu-Pacheco (1) for their comments on our study (2). As Kanna and Abreu-Pacheco point out, overweight and obesity are strongly linked to the development of type 2 diabetes and can complicate its management. While most patients with type 2 diabetes are overweight (3), this study (2) included individuals with a range of BMI values typical of those seen in clinical practice; mean BMI in the inhaled insulin and glibenclamide groups was 31.8 (range 19–51) and 31.1 (22–47), respectively. When analyzed by baseline BMI values, the mean change from baseline A1C in the moderately high A1C arm (8 to 9.5%) was –1.6, –1.3, and –1.5% in patients with baseline BMI values of <30, 30–35, and 35 kg/m², respectively, compared with –1.5% for all subjects. In the very high A1C arm (>9.5%), mean change from baseline A1C was –3.1, –2.8, and –2.8% in patients with baseline BMI values of <30, 30–35, and 35 kg/m², respectively, compared with –2.9% for all subjects. The results show no meaningful differences between the BMI categories, and the authors therefore believe it to be unlikely that the baseline BMI values could have confounded the A1C results.

For the duration of the study, patients were required to follow an American Diabetes Association diet (with 30% fat and calories sufficient to maintain ideal body weight) and to perform 30 min of moderate exercise at least 3 days per week. There was no specific measure of compliance with diet and exercise regimens during the study, but patients were reminded of their importance at each clinic visit.

Finally, we would like to point out that our study was open label and not blinded. As highlighted in the article, a double-blind study, while desirable, was not possible for two principal reasons: 1) it was not possible to manufacture a suitable placebo for inhaled insulin, and 2) it is generally inappropriate to blind treatment when individualized flexible dose titration is needed for effective management with exogenous insulin.

Footnotes

M.S.-P. is an employee of Pfizer.

References

1. Kanna B, Abreu-Pacheco H: An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with glibenclamide as adjunctive therapy in patients with type 2 diabetes poorly controlled on metformin (Letter). Diabetes Care 30:445–446, 2007[Free Full Text]
   
2. Barnett AH, Dreyer M, Lange P, Serdarevic-Pehar M, the Exubera Phase III Study Group: An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (Exubera) with glibenclamide as adjunctive therapy in patients with type 2 diabetes poorly controlled on metformin. Diabetes Care 29:1818–1825, 2006[Abstract/Free Full Text]
   
3. Daousi C, Casson IF, Gill GV, MacFarlane IA, Wilding JPH, Pinkney JH: Prevalence of obesity in type 2 diabetes in secondary care: association with cardiovascular risk factors. Postgrad Med J 82:280–284, 2006[Abstract/Free Full Text]
   

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