Will availability of inhaled human insulin (Exubera®) improve management of type 2 diabetes? The design of the Real World trial

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Will availability of inhaled human insulin (Exubera®) improve management of type 2 diabetes? The design of the Real World trial

Publisher
BioMed Central
Publication Date
Aug 10, 2006
Source
PMC
Keywords
Disciplines
  • Design
  • Medicine
  • Psychology
License
Unknown

Abstract

1745-6215-7-25.fm ral ss BioMed CentTrials Open AcceStudy protocol Will availability of inhaled human insulin (Exubera®) improve management of type 2 diabetes? The design of the Real World trial Nick Freemantle*1, Thomas R Strack*2 and the Real World Trialists Address: 1University of Birmingham, Birmingham, UK and 2Pfizer Inc, New York, NY, USA Email: Nick Freemantle* - [email protected]; Thomas R Strack* - [email protected] * Corresponding authors Abstract Background: Common deterrents to insulin therapy for both physicians and patients are the complexity and burden of daily injections. In January 2006, the first inhaled human insulin (INH, Exubera® (insulinhuman [rDNA origin])InhalationPowder) was approved for use in adult patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) in the United States and European Union. Results from the INH clinical trial program have shown comparable efficacy of INH to subcutaneous (SC) insulin and superior efficacy versus oral antidiabetic agents; thus providing effective glycemic control in adult patients with T2DM without the requirement for preprandial injections. However, because subjects in those trials were randomized to either INH or an alternative, the studies could not estimate the effect of INH on patient acceptance of insulin therapy. Therefore, traditional study designs cannot provide answers to important and practical questions regarding real world effectiveness, which is influenced by psychological and other access barriers. Methods: To overcome these limitations, the Real World Trial was designed to estimate the effect of the availability of INH as a treatment option for glycemic control. A total of approximately 700 patients from Canada, France, Germany, Italy, Spain, United Kingdom, and the United States with T2DM poorly controlled by oral agent therapy will be randomized to two different treatment settings. Patients and clinicians in both groups (A & B) may choose from all license

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