Efficacy of Inhaled Insulin in Patients With Type 2 Diabetes not Controlled With Diet and Exercise

Abstract

OBJECTIVE -Effective type 2 diabetes management requires prompt intervention if glycemic control is not achieved by nonpharmacological means. This study investigates whether inhaled insulin (INH; Exubera) can achieve target glycemic control in patients failing on diet and exercise.RESEARCH DESIGN AND METHODS -Patients with suboptimal control on diet and exercise (HbA 1c [A1C] 8 -11%) were randomized to 3 months' treatment with either INH before meals (n ϭ 76) or rosiglitazone 4 mg twice a day (n ϭ 69), in conjunction with a diet and exercise regimen. The primary end point was percentage of patients achieving A1C Ͻ8.0%. CONCLUSIONS -INH could be an effective therapy for people with type 2 diabetes early in the course of their disease. RESULTS

Influence of magnesium stearate on the physicochemical and pharmacodynamic characteristics of insulin-loaded Eudragit entrapped mucoadhesive microspheres

“…It implies that magnesium stearate potentiated the mucoadhesiveness of insulin-loaded Eudragit Õ entrapped microspheres in SIF. The high percentage mucoadhesion of the different batches of the microspheres in SIF signifies high mucoadhesive property in intestinal condition where insulin absorption takes place (Yamamoto et al, 1994;Chetty & Chien, 1998;Rosenstock, 2001;Dorkoosh, 2002;Eaimtrakarn et al, 2002;Cefalu, 2004;Chung, 2004;Attivi, 2005;DeFronzo et al, 2005;Ahmed & Goldstein, 2006;Chalasani, 2007;Cui, 2007;Damage et al, 2007;Evans et al, 2011;Akhter & Nijhu, 2012). This shows that the insulin-loaded microspheres will have a prolonged release and thereby enhance bioavailability of insulin, consistent with previous reports (Rosa et al, 2000;Jain et al, 2005;Builders et al, 2008a).…”

“…Various approaches that could be adopted include modification of physicochemical properties such as lipophilicity and enzyme susceptibility, addition of novel function to macromolecules as well as the use of improved carrier system. In other words, methods like protecting insulin from enzymatic degradation, use of penetration enhancers, chemical modification, bioadhesive delivery system, as well as use of carrier systems could help to improve bioavailability of insulin (Heinemann et al, 2001;Rosenstock, 2001;Dorkoosh, 2002;Eaimtrakarn et al, 2002;Heinemann, 2002;Cefalu, 2004;Chung, 2004;Attivi, 2005;DeFronzo et al, 2005;Jain et al, 2005;Kavimandan, 2006;Chalasani, 2007;Cui, 2007;Damge et al, 2007;Ichikawa & Fukumori, 2007). The successful production of an effective oral insulin formulation will depend on the development of an appropriate drug delivery (carrier) system that will protect insulin from the degradative effect of enzymes and pH of the GIT (Caliceti & Veronese, 1999).…”

Inhaled insulin (Exubera®): combining efficacy and convenience

“…27 Patients who received inhaled insulin had greater reductions in HbA 1C (-2.3% vs. -1.4%) and a significant proportion of them achieved the target HbA 1C (HbA 1C < 8.0% 83% vs. 58%, HbA 1C < 7.0% 44% vs. 18%, and HbA 1C < -6.5% 28% vs. 7.5%).…”

Introduction: inhaled insulins:potential therapies for diabetes mellitus

“…To date, Exubera is the only inhaled insulin formulation that has extensively investigated pulmonary function in comprehensive detail, with several completed and ongoing Phase 3 studies in patients with type 1 or with type 2 diabetes. Data from these extensive pulmonary safety studies are covered in detail within the review article by Dr Leonardo Fabbri 25 , and provide reassurance that Exubera is generally well tolerated [16][17][18][19][20][21][22][23]25 . Declines in forced expiratory volume in 1 second (FEV 1 ) have been observed with Exubera treatment relative to comparator; however, the changes in pulmonary function are small.…”

“…In various studies, Exubera has achieved and maintained effective glycemic control comparable to subcutaneous fast-acting human insulin regimens in patients with type 1 or type 2 diabetes [16][17][18][19] . Furthermore, in patients with type 2 diabetes failing oral antidiabetic agents (OAs), those using Exubera alone or in combination with OAs achieved greater improvements in HbA 1c [20][21][22][23] . The efficacy and general safety findings are discussed by Dr Stefano Del Prato within the second review article of this supplement 24 .…”