Bruce W Bode1, Janet B McGill2, Daniel L Lorber3, Jorge L Gross4, P C Chang5, David B Bregman6. 1. Atlanta Diabetes Associates, Atlanta, GA bbode001@aol.com. 2. Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine in St. Louis, St. Louis, MO. 3. New York Hospital Queens, New York-Presbyterian Healthcare System, Flushing, NY. 4. Centro de Pesquisas em Diabetes Ltda., Porto Alegre, Brazil. 5. MannKind Corporation, Paramus, NJ. 6. Sanofi, Bridgewater, NJ Department of Pathology, Albert Einstein College of Medicine, Bronx, NY.
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.
RCT Entities:
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 TIpatients (-0.21% [-2.3 mmol/mol]) from baseline (7.94% [63.3 mmol/mol]) was noninferior to that in aspartpatients (-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 aspartpatients achieved HbA1c <7.0% (53.0 mmol/mol) (30.7% vs. 18.3%). TIpatients had a small weight loss (-0.4 kg) compared with a gain (+0.9 kg) for aspartpatients (P = 0.0102). TIpatients had a lower hypoglycemia event rate than aspartpatients (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: Alfonso Galderisi; Nathan Cohen; Peter Calhoun; Kristen Kraemer; Marc Breton; Stuart Weinzimer; Eda Cengiz Journal: Diabetes Care Date: 2020-07-13 Impact factor: 19.112
Authors: Laura M Nally; Jennifer L Sherr; Michelle A Van Name; Anisha D Patel; William V Tamborlane Journal: Expert Rev Clin Pharmacol Date: 2019-05 Impact factor: 5.045