title: Inhaled Technosphere Insulin Compared With Injected Prandial Insulin in Type 1 Diabetes: A Randomized 24-Week Trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of Technosphere insulin (TI) and insulin aspart in patients with type 1 diabetes.
  
  
  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.
authors.affiliation: Atlanta Diabetes Associates, Atlanta, GA bbode001@aol.com.
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Bode
authors.affiliation: Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine in St. Louis, St. Louis, MO.
authors.forename: Janet B
authors.initials: JB
authors.lastname: McGill
authors.affiliation: New York Hospital Queens, New York-Presbyterian Healthcare System, Flushing, NY.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Lorber
authors.affiliation: Centro de Pesquisas em Diabetes Ltda., Porto Alegre, Brazil.
authors.forename: Jorge L
authors.initials: JL
authors.lastname: Gross
authors.affiliation: MannKind Corporation, Paramus, NJ.
authors.forename: P C
authors.initials: PC
authors.lastname: Chang
authors.affiliation: Sanofi, Bridgewater, NJ Department of Pathology, Albert Einstein College of Medicine, Bronx, NY.
authors.forename: David B
authors.initials: DB
authors.lastname: Bregman
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D061267:Insulin Aspart / Q000008:administration & dosage* / Q000627:therapeutic use; D061386:Insulin, Regular, Human / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D011208:Powders / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D061386:Insulin, Regular, Human; D011208:Powders