{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T19:25:23Z","timestamp":1793129123887,"version":"4.5.0"},"reference-count":25,"publisher":"American Diabetes Association","issue":"12","funder":[{"DOI":"10.13039\/100014598","name":"MannKind Corporation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100014598","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2015,12,1]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>To compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                    <jats:p>This open-label noninferiority trial compared the change in HbA1c from baseline to week 24 of prandial TI (n = 174) with that of subcutaneous aspart (n = 171), both with basal insulin, in patients with type 1 diabetes and HbA1c 7.5\u201310.0% (56.8\u201386.0 mmol\/mol).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Mean change in HbA1c in TI patients (\u20130.21% [\u20132.3 mmol\/mol]) from baseline (7.94% [63.3 mmol\/mol]) was noninferior to that in aspart patients (\u20130.40% [\u20134.4 mmol\/mol]) from baseline (7.92% [63.1 mmol\/mol]). The between-group difference was 0.19% (2.1 mmol\/mol) (95% CI 0.02\u20130.36), satisfying the noninferiority margin of 0.4%. However, more aspart patients achieved HbA1c &amp;lt;7.0% (53.0 mmol\/mol) (30.7% vs. 18.3%). TI patients had a small weight loss (\u20130.4 kg) compared with a gain (+0.9 kg) for aspart patients (P = 0.0102). TI patients had a lower hypoglycemia event rate than aspart patients (9.8 vs. 14.0 events\/patient-month, P &amp;lt; 0.0001). Cough (generally mild) was the most frequent adverse event (31.6% with TI, 2.3% with aspart), leading to discontinuation in 5.7% of patients. Treatment group difference for mean change from baseline in forced expiratory volume in 1 s was small (40 mL) and disappeared upon TI discontinuation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>In patients with type 1 diabetes receiving basal insulin, HbA1c reduction with TI was noninferior to that of aspart, with less hypoglycemia and less weight gain but increased incidence of cough.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/dc15-0075","type":"journal-article","created":{"date-parts":[[2015,7,15]],"date-time":"2015-07-15T22:40:32Z","timestamp":1437000032000},"page":"2266-2273","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":109,"title":["Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial"],"prefix":"10.2337","volume":"38","author":[{"given":"Bruce W.","family":"Bode","sequence":"first","affiliation":[{"name":"Atlanta Diabetes Associates, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet B.","family":"McGill","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine in St. Louis, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel L.","family":"Lorber","sequence":"additional","affiliation":[{"name":"New York Hospital Queens, New York-Presbyterian Healthcare System, Flushing, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge L.","family":"Gross","sequence":"additional","affiliation":[{"name":"Centro de Pesquisas em Diabetes Ltda., Porto Alegre, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.-C.","family":"Chang","sequence":"additional","affiliation":[{"name":"MannKind Corporation, Paramus, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David B.","family":"Bregman","sequence":"additional","affiliation":[{"name":"Sanofi, Bridgewater, NJ"},{"name":"Department of Pathology, Albert Einstein College of Medicine, Bronx, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Affinity 1 Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2015,7,15]]},"reference":[{"key":"2022031220263779400_B1","doi-asserted-by":"crossref","first-page":"1505","DOI":"10.1016\/S0140-6736(97)06234-X","article-title":"Adherence to insulin treatment, glycaemic control, and ketoacidosis in insulin-dependent diabetes mellitus. 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