Inhaled dry powder insulin for the treatment of diabetes mellitus

• Published in: Clinical therapeutics 2007-05, Vol.29 (5), p.795-813
• Main Authors: Setter, Stephen M., PharmD, CDE, DVM, Levien, Terri L., PharmD, Iltz, Jason L., PharmD, CDM, Odegard, Peggy Soule, PharmD, BCPS, CDES, Neumiller, Joshua J., PharmD, Baker, Danial E., PharmD, FASCP, FASHP, Campbell, R. Keith, RPh, MBA, CDE, FASHP
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Biological and medical sciences; Clinical trials; Clinical Trials as Topic; Contraindications; Diabetes; Diabetes Mellitus - drug therapy; Diabetes Mellitus - economics; Diabetes Mellitus, Type 1 - drug therapy; Diabetes Mellitus, Type 2 - drug therapy; Diabetes. Impaired glucose tolerance; Drug Interactions; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Etiopathogenesis. Screening. Investigations. Target tissue resistance; Exubera; Humans; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - economics; Hypoglycemic Agents - pharmacokinetics; Hypoglycemic Agents - therapeutic use; IDPI; inhaled dry powder insulin; inhaled insulin; Insulin; Insulin - administration & dosage; Insulin - adverse effects; Insulin - economics; Insulin - pharmacokinetics; Insulin - therapeutic use; Internal Medicine; Medical Education; Medical sciences; Patient satisfaction; Pharmacology. Drug treatments; Powders; type 1 diabetes; type 2 diabetes
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2007.05.015

Abstract Background: Inhaled dry powder insulin (IDPI) is the first inhaled insulin approved for the treatment of type 1 and type 2 diabetes mellitus (DM). Objective: This article reviews available information on IDPI, focusing on its clinical pharmacokinetics, comparative efficacy, tolerability, adverse events, dosage and administration, and cost. Methods: MEDLINE (1966–July 2006) and Web of Science (1995–July 2006) were searched for original research and review articles published in English. The search terms used were inhaled insulin, inhaled human insulin, rDNA origin inhalation powder, inbaled dry powder insulin , and IDPI . All published comparative efficacy studies were included in the review, as well as selected information from the package insert for IDPI. Results: IDPI is an inhaled dry powder form of regular human insulin (RHI) that is used as a premeal insulin to improve glycemic control by reducing postprandial glucose excursions. The literature search identified 5 efficacy trials comparing reductions in glycosylated hemoglobin (HbA1c ) in a total of 582 patients with type 1 DM who received either premeal IDPI plus neutral protamine Hagedorn (NPH) or Ultralente insulin or injectable RHI plus NPH or Ultralente insulin. The search identified 5 comparative efficacy studies of IDPI monotherapy or the addition of IDPI to the current regimen in a total of 1413 patients with type 2 DM that was uncontrolled with diet and exercise, metformin, a sulfonylurea, metformin and a sulfonylurea, or a secretagogue plus an insulin sensitizer. The use of IDPI as a mealtime insulin in these studies was associated with absolute changes in HbA1c ranging from −0.6% to +0.1% in patients with type 1 DM and from −1.4% to −2.9% in patients with type 2 DM. HbA1c values