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Treatment Satisfaction With Inhaled Insulin in Patients With Type 1 Diabetes

A randomized controlled trial

  1. Robert A. Gerber, PHARMD, MA1,
  2. Joseph C. Cappelleri, PHD, MPH1,
  3. Ione A. Kourides, MD2 and
  4. Robert A. Gelfand, MD1
  1. 1Pfizer Inc., Global Research and Development, Groton, Connecticut
  2. 2Pfizer Inc., New York, New York

    Abstract

    OBJECTIVE—In patients with type 1 diabetes, glycemic control can be achieved as effectively with an inhaled insulin regimen, comprising preprandial inhaled intrapulmonary insulin plus a bedtime ultralente injection, as with a conventional subcutaneous insulin regimen involving two to three injections per day. Our objective was to compare patient satisfaction between inhaled insulin and subcutaneous insulin.

    RESEARCH DESIGN AND METHODS—Subjects with type 1 diabetes participated in a 12-week open-label trial and were randomized to either an inhaled insulin regimen or a subcutaneous insulin regimen. Subjects (n = 69) were asked to complete a 15-item self-administered satisfaction questionnaire, the Patient Satisfaction with Insulin Therapy (PSIT) Questionnaire, at baseline and week 12. Outcomes included mean percentage changes in global (overall) satisfaction and two subscales: convenience/ease of use and social comfort.

    RESULTS—The mean percentage improvement in overall satisfaction with inhaled insulin (35.1%, 95% CI 18.0–52.2) was greater than with subcutaneous insulin (10.6%, 4.7–16.5) (P < 0.01), as was the improvement in convenience/ease of use: inhaled insulin 41.3% (22.9–59.6) versus subcutaneous insulin 11.2% (4.1–18.3; P < 0.01). Improvement in social comfort was greater with inhaled insulin but was not statistically significant. The 12-week change in HbA1c was associated with improved overall satisfaction (r = −0.27, P = 0.04).

    CONCLUSIONS—Inhaled insulin may offer the first practical, noninvasive alternative to insulin injections. For patients with type 1 diabetes, inhaled insulin maintains glycemic control and provides greater overall satisfaction and convenience/ease of use than subcutaneous insulin.

    Footnotes

    • Address correspondence and reprint requests to Robert A. Gerber, PharmD, MA, Pfizer Inc., M.S. 8260–208, Global Research and Development, Eastern Point Road, Groton, CT 06340. E-mail: robert_a_gerber{at}groton.pfizer.com.

      Received for publication 22 February 2001 and accepted in revised form 16 May 2001.

      All authors are employed by and hold stock in Pfizer Inc., which develops, manufactures, and markets pharmaceuticals related to the treatment of diabetes.

      A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

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