Body Weight Changes Associated With Insulin Therapy

A retrospective pooled analysis of inhaled human insulin (Exubera) versus subcutaneous insulin in five controlled Phase III trials

  1. Priscilla A. Hollander, MD, PHD1,
  2. Alan Krasner, MD2,
  3. Sol Klioze, PHD2,
  4. Pamela Schwartz, PHD2 and
  5. William Duggan, PHD2
  1. 1Baylor Endocrine Center, Baylor University Medical Center, Dallas, Texas
  2. 2Pfizer Global Research, New London, Connecticut
  1. Address correspondence and reprint requests to Priscilla A. Hollander, Baylor University Medical Center, 3600 Gaston Ave., Wadley Tower, Suite 656, Dallas, TX 75246. E-mail: priscilh{at}baylorhealth.edu

Weight gain is commonly seen when patients are started on subcutaneous (SC) insulin. In the UK Prospective Diabetes Study, those assigned insulin gained 4 kg more than those assigned conventional therapy at 10 years (1). Given that the majority of patients with type 2 diabetes are overweight or obese (2,3), additional weight gain is clearly a concern. Furthermore, while patients with type 1 diabetes were historically often underweight, the greater use of an intensified treatment approach to achieve the benefits of improved glycemic control is associated with greater weight gain than conventional treatment (4). Fear of weight gain, along with factors such as reluctance to self-inject and fear of hypoglycemia, is a frequent deterrent to initiating insulin therapy and has been linked to reduced treatment adherence in patients with both type 1 and type 2 diabetes (5).

In type 2 diabetes, the β-cell dysfunction that leads to impaired insulin secretion is progressive, and eventually patients will require a treatment strategy that includes insulin either alone or with oral agents (6). The aim of this pooled analysis was to compare weight changes in a large population of adult patients with type 1 or type 2 diabetes receiving a regimen involving inhaled human insulin (Exubera [rDNA origin] Inhalation Powder) versus an SC insulin–only regimen.

RESEARCH, DESIGN AND METHODS—

This was a retrospective analysis of pooled 6-month data from five controlled Phase III clinical trials …

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