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

Freemantle, N; Strack, TR; Real World Trialists; (2006) Will availability of inhaled human insulin (Exubera (R)) improve management of type 2 diabetes? The design of the Real World trial. Trials , 7 , Article 25. 10.1186/1745-6215-7-25. Green open access

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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(R) (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 licensed therapies for diabetes including SC insulin delivered by pens; INH will be an additional treatment option only available in Group A. The Real World Trial ( Protocol A2171018) has been registered with ClincalTrials. gov, registration id NCT00134147.Results: The primary outcome for the trial will be the difference in mean glycosylated hemoglobin (HbA(1c)) at 6 months between groups. The design was based on a preceding feasibility study examining the theoretical effects of inhaled insulin availability on treatment choice in 779 patients. In that study, patients were three times more likely to choose insulin therapy when inhaled insulin was available.Conclusion: Innovations in study designs may provide an opportunity to reveal unbiased answers to important treatment questions that are more relevant to prescribers, funding agencies, and healthcare policymakers.

Type: Article
Title: Will availability of inhaled human insulin (Exubera (R)) improve management of type 2 diabetes? The design of the Real World trial
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/1745-6215-7-25
Publisher version: http://dx.doi.org/10.1186/1745-6215-7-25
Language: English
Additional information: © 2006 Freemantle et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Treatment satisfaction, glycemic control, long-term, therapy, efficacy, mellitus, safety, complications, retinopathy, smoking
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > Comprehensive CTU at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/1315426
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