Inhaled Insulin: Exubera

2005 ◽  
Vol 39 (5) ◽  
pp. 843-853 ◽  
Author(s):  
Peggy Soule Odegard ◽  
Kam L Capoccia

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of Exubera, a novel, dry-powder formulation of insulin for inhalation, and describe patient satisfaction and quality-of-life data. DATA SOURCES: A MEDLINE search (1966–November 2004) was conducted using the key words inhaled insulin and Exubera for clinical trials limited to human research published in English. BIOSIS Previews and the American Diabetes Association Scientific Abstracts were used for published abstract information. STUDY SELECTION AND DATA EXTRACTION: All available human studies of Exubera were selected for review. References of identified articles were used for additional citations. DATA SYNTHESIS: Exubera is a rapid-acting insulin administered by oral inhalation before meals with long-acting insulin administered subcutaneously once or twice daily for type 1 or 2 diabetes mellitus. Exubera provides similar efficacy and improved patient satisfaction compared with standard subcutaneous insulin therapy (ie, NPH twice daily with regular insulin before meals). Efficacy has also been demonstrated for Exubera when used as adjunctive therapy with oral medications for type 2 diabetes. The onset of Exubera is more rapid and its duration of action is similar to that of regular insulin. To date, Exubera administered before meals with a once-daily long-acting subcutaneous insulin (usually Ultralente) has been compared with standard subcutaneous NPH/regular insulin regimens. Comparison of premeal Exubera plus a basal long-acting insulin analog (eg, glargine) with a regimen of premeal subcutaneous rapid-acting insulin analog (eg, lispro or aspart) plus a basal long-acting insulin analog (eg, glargine) is needed to fully evaluate Exubera. Pulmonary safety appears to be maintained for up to 4 years, although there are no data, as of this writing, on the use of this agent in patients with pulmonary conditions. CONCLUSIONS: Exubera is an effective inhaled insulin for preprandial use in type 1 or 2 diabetes. Improved patient satisfaction over injected insulin increases its potential for use earlier in the treatment of type 2 diabetes.

Diabetes Care ◽  
2004 ◽  
Vol 27 (6) ◽  
pp. 1318-1323 ◽  
Author(s):  
J. Rosenstock ◽  
J. C. Cappelleri ◽  
B. Bolinder ◽  
R. A. Gerber

2009 ◽  
Vol 43 (4) ◽  
pp. 658-668 ◽  
Author(s):  
Kristen L Helms ◽  
Kristi W Kelley

Objective: To evaluate the pharmacodynamic properties, efficacy, safety, and clinical application of insulin glulisine, a rapid-acting insulin analog, in the treatment of diabetes mellitus in ambulatory and hospitalized patients. Data Sources: Searches were performed with the headings glulisine, insulin analog, [LysB3, GluB29] insulin, insulin glulisine, rDNA insulin, rapid-acting insulin, SoloStar, safety, efficacy, pharmacodynamics, and cost analysts within MEDLINE and PubMed, American Diabetes Association (ADA), the Food and Drug Administration (FDA), and Sanofi-aventis Pharmaceuticals (1990–August 2008). Study Selection and Data Extraction: Phase 1, Phase 2, Phase 3, and postmarketing trials examining the efficacy and safety of glulisine in type 1 or type 2 diabetes were reviewed. Studies published as abstracts and the manufacturer's product information supplemented data absent from clinical trials. Data Synthesis: Insulin glulisine is a rapid-acting insulin with relative equivalence in efficacy and safety to other short- and rapid-acting insulins. Glulisine's onset of action of 20 minutes and 4-hour duration of action allow for bolus administration 15–20 minutes prior to or up to 20 minutes after meals. Clinical trials have demonstrated the safety and efficacy in adults with type 1 or type 2 diabetes. Several studies indicated a statistically significant decrease of hemoglobin A1C (A1C) with glulisine compared with regular insulin (0.10 decrease); however, no difference in A1C control was found compared with insulin aspart or lispro, Significant adverse effects appear to be limited to localized and systemic allergic reactions and hypoglycemia. Conclusions: Insulin glulisine is a safe and effective rapid-acting insulin analog for the treatment of adults with diabetes. Clinical benefit over other short- and rapid-acting insulin products is not established. Addition of insulin glulisine to a formulary should be based on institution-specific availability and cost differences between glulisine, lispro, and aspart in the absence of superiority of clinical efficacy or safety and data beyond 26 weeks.


2011 ◽  
Vol 33 (9) ◽  
pp. 1258-1267 ◽  
Author(s):  
Andrew Lloyd ◽  
Beenish Nafees ◽  
Anthony H. Barnett ◽  
Simon Heller ◽  
Uffe J. Ploug ◽  
...  

2002 ◽  
Vol 36 (6) ◽  
pp. 1019-1027 ◽  
Author(s):  
Terri L Levien ◽  
Danial E Baker ◽  
John R White ◽  
R Keith Campbell

OBJECTIVE: To review the pharmacology, pharmacokinetics, dosing guidelines, adverse effects, drug interactions, and clinical efficacy of insulin glargine. DATA SOURCES: Primary and review articles regarding insulin glargine were identified by MEDLINE search (1966–July 2001); abstracts were identified through Institute for Scientific Information Web of Science (1995–July 2001) and the American Diabetes Association. Additional information was obtained from the insulin glargine product information. STUDY SELECTION AND DATA EXTRACTION: All of the articles and meeting abstracts identified from the data sources were evaluated, and all information deemed relevant was included in this review. Priority was placed on data from the primary medical literature. DATA SYNTHESIS: Insulin glargine is a long-acting, recombinant human insulin analog that is given once daily as a basal source of insulin in patients with type 1 or type 2 diabetes mellitus. Modification of the basic insulin structure has produced a new insulin that is soluble at an acidic pH, but precipitates in the subcutaneous tissue and is slowly released from a depot. Insulin glargine has a slower onset of action than NPH insulin and a longer duration of action with no peak activity. Once-daily administration of insulin glargine has comparable efficacy to that of NPH insulin administered once or twice daily in basal-bolus regimens when used in combination with intermittent doses of regular insulin or insulin lispro in patients with type 1 and type 2 diabetes, and in conjunction with oral antidiabetic agents in patients with type 2 diabetes. Overall, insulin glargine has an incidence of hypoglycemia comparable to or less than that of NPH insulin, with a reduced incidence of nocturnal hypoglycemia compared with NPH insulin seen in some studies. CONCLUSIONS: Insulin glargine is a long-acting insulin analog capable of providing 24-hour basal insulin coverage when administered once daily at bedtime. Its activity profile, which lacks a pronounced peak, more closely resembles that of endogenous basal insulin than that of other intermediate- or long-acting insulins and appears more likely to be associated with a reduced incidence of hypoglycemia, particularly nocturnal hypoglycemia. Insulin glargine physiologically provides basal insulin but, for most patients, the addition of a rapid-acting insulin, like insulin lispro, before or with meals will need to be included in the treatment regimen to achieve optimal management of blood glucose concentrations.


2010 ◽  
Vol 27 (4) ◽  
pp. 211-222 ◽  
Author(s):  
Edith M. Heintjes ◽  
Trine L. Thomsen ◽  
Fernie J. A. Penning-van Beest ◽  
Torsten E. Christensen ◽  
Ron M. C. Herings

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