Inhaled technosphere insulin compared with injected prandial insulin in type 1 diabetes: A randomized 24-week trial

Bruce W. Bode, Janet B. McGill, Daniel L. Lorber, Jorge L. Gross, P. C. Chang, David B. Bregman

Research output: Contribution to journalArticlepeer-review

52 Scopus citations

Abstract

OBJECTIVE To compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS 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 7.5-10.0% (56.8- 86.0 mmol/mol). RESULTS Mean change in HbA1c in TI patients (-0.21% [-2.3 mmol/mol]) from baseline (7.94% [63.3 mmol/mol]) was noninferior to that in aspart patients (-0.40% [-4.4 mmol/mol]) from baseline (7.92% [63.1 mmol/mol]). The between-group difference was 0.19% (2.1 mmol/mol) (95% CI 0.02-0.36), satisfying the noninferiority margin of 0.4%. However,more aspart patients achieved HbA1c <7.0% (53.0 mmol/mol) (30.7% vs. 18.3%). TI patients had a small weight loss (-0.4 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 < 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. CONCLUSIONS 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.

Original languageEnglish
Pages (from-to)2266-2273
Number of pages8
JournalDiabetes care
Volume38
Issue number12
DOIs
StatePublished - Dec 2015

Fingerprint

Dive into the research topics of 'Inhaled technosphere insulin compared with injected prandial insulin in type 1 diabetes: A randomized 24-week trial'. Together they form a unique fingerprint.

Cite this