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Diabetes Care 30:445-446, 2007
DOI: 10.2337/dc06-2031
© 2007 by the American Diabetes Association
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Letters: Comments and Responses

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 Barnett et al.

Balavenkatesh Kanna, MD, MPH1,2 and Heidi Abreu-Pacheco, MD1

1 Department of Internal Medicine, Lincoln Medical & Mental Health Center, Bronx, New York
2 Weill Medical College of Cornell University, New York, New York

Address correspondence to Balavenkatesh Kanna, MD, MPH, Department of Medicine, Suite 8-22, 8th Floor, 234 E. 149th St., Bronx, NY 10451. E-mail: balavenkatesh.kanna{at}nychhc.org

In response to the interesting article by Barnett et al. (1), we would like to offer the following comments. Diabetes control has been shown to improve with diet and exercise regimens (2,3). The degree of study participants’ compliance with diet and exercise regimens may have confounded the change in A1C reported in the study (1). Also, the independent effect of BMI on both diabetes control and response to therapy has been studied extensively (4). The effect of modification of baseline BMI on diabetes control among various strata of BMI in both study groups needs clarification.

The open-blinded design of the study (1), especially since it involves diabetes education and self monitoring, can significantly impact internal validity due to both performance bias of the subject with respect to compliance with lifestyle modifications as well as detection bias of the health care providers in ascertaining adverse outcomes (5). In addition, the noninferiority design offers no protection against a predetermined idea of equivalence by the investigator, who could allocate similar scores to responses and events of all study subjects (6).

References

  1. 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]
  2. Sigal RJ, Kenny GP, Wasserman DH, Castaneda-Sceppa C, White RD: Physical activity/exercise and type 2 diabetes: a consensus statement from the American Diabetes Association. Diabetes Care 29:1433–1438, 2006[Free Full Text]
  3. American Diabetes Association: Nutrition recommendations and interventions for diabetes: a position statement of the American Diabetes Association (Position Statement). Diabetes Care 29:2140–2157, 2006[Free Full Text]
  4. Klein S, Sheard NF, Pi-Sunyer X, Daly A, Wylie-Rosett J, Kulkarni K, Clark NG: Weight management through lifestyle modification for the prevention and management of type 2 diabetes: rationale and strategies: a statement of the American Diabetes Association, the North American Association for the Study of Obesity, and the American Society for Clinical Nutrition. Diabetes Care 27:2067–2073, 2004[Free Full Text]
  5. Norris SL, Engelgau MM, Venkat Narayan KM: Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care 24:561–587, 2001[Abstract/Free Full Text]
  6. Snapinn SM: Noninferiority trials. Curr Control Trials Cardiovasc Med 1:19–21, 2000[Medline]

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A. H. Barnett, M. Dreyer, P. Lange, M. Serdarevic-Pehar, and on behalf of 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: Response to Kanna and Abreu-Pacheco
Diabetes Care, February 1, 2007; 30(2): 446 - 446.
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