Open Access了解吸入性胰岛素:1型糖尿病早期随机试验的结果
Author(s) -
McGill Janet B.,
Weiss Daniel,
Grant Marshall,
Jones Marisa C.,
Kendall David M.,
Hoogwerf Byron J.
Publication year - 2021
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.13099
Subject(s) - medicine , insulin lispro , hypoglycemia , discontinuation , insulin , diabetes mellitus , type 2 diabetes mellitus , clinical endpoint , adverse effect , randomized controlled trial , type 2 diabetes , gastroenterology , endocrinology
Background Technosphere Insulin (TI) is an inhaled insulin. Studies comparing TI with short‐acting insulin analogues provide important insights on efficacy, dosing, and time course of action. Methods Planned enrollment of 230 subjects was limited to 138 due to premature study discontinuation. The primary efficacy endpoint was a noninferiority of glycosylated hemoglobin (HbA1c) of 0.4% for TI compared with insulin lispro (LIS) in a 16‐week phase 3 randomized clinical trial in type 1 diabetes mellitus. Results HbA1c values were similar in the TI and LIS groups at the beginning of the trial (7.8% and 7.6%, respectively) and at trial endpoint (7.7% and 7.6%, respectively). Least squares mean changes from baseline were similar between study groups. Glucose values after a standard meal were significantly lower with TI in the first 90 minutes post meal compared with LIS. Mild or moderate hypoglycemia event rates were also significantly lower with TI compared with LIS (5.97 vs 8.01, respectively; P = .0269). Cough was the most commonly reported adverse event with TI. Pulmonary function as measured by forced expiratory volume in 1 second was not different between groups at baseline, 16 weeks, or 4 weeks off study drug. Conclusions HbA1c was unchanged and overall glucose control was comparable between groups. Treatment with TI resulted in improved post‐meal glucose and a lower risk of hypoglycemia compared with LIS.