|The following article is part of conference coverage from the American Diabetes Association’s 78th Scientific Sessions (ADA 2018) in Orlando,Florida. Endocrinology Advisor’s staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back for the latest news from ADA 2018.|
ORLANDO – In patients with type 1 diabetes (T1D), Technosphere inhaled insulin (TI) can improve postprandial blood glucose (PPBG), increase time-in-range (70 to 180 mg/dL), and reduce hypoglycemic events compared with insulin aspart, according to results from 3 studies presented at the American Diabetes Association’s 78th Scientific Sessions held in Orlando, Florida, June 22-26, 2018.
The first study, which is a part of the STAT study, included 60 participants with T1D on multiple daily injections who were randomly assigned to TI (n=26) or insulin aspart (n=34), the control group.1 Participants in the TI arm were told to take extra inhalations 1 and 2 hours after meals based on postprandial blood glucose. The researchers examined outcomes over a 4-week period.
Both the TI and aspart groups had similar mean continuous glucose monitoring (CGM) rates, time in range (70-180 mg/dL), and percent of time in hyper- (>180 mg/dL) or hypoglycemia (<70, <60, or <50 mg/dL). Compared with the aspart group, the TI group had lower PPBG at 1 hour (mean ± SE PPBG difference −31.7±6.6 mg/dL, P <.0001) and at 2 hours after meals (mean ± SE PPBG −13.0±7.1 mg/dL, P =.07). At 3 to 4 hours, there was no difference in PPBG between the groups.
In a second study, which is a part of the STAT study, the researchers analyzed results from the same 60 participants to determine TI’s effect on CGM data, with a primary outcome of time-in-range (70 to 180 mg/dL).2
The researchers defined compliance with TI as using it when indicated at 1- and 2- hours PPBG. Participants who had at least 80% compliance were included in the per protocol analysis (n=15). There were 7 non-compliant participants, 2 who dropped out of the study, and 2 who did not have CGM data. Participants in the TI group had significantly higher rates of time-in-range (approximately 60%) compared with TI-non-compliant (approximately 45%) and control participants (approximately 55%).
In another study, researchers conducted a post-hoc analysis of participants with reported glycated hemoglobin A1c (HbA1c) values at the end of treatment during the AFFINITY-1 study.3 AFFINITY-1 was a treat-to-target study of participants with T1D on multiple daily injection therapy. It demonstrated that an ultra-short acting insulin, TI (Afrezza®), was non-inferior to subcutaneous insulin aspart in HbA1C reduction.4 In their study, the researchers found that participants using TI had significantly lower mean rates of hypoglycemia and severe hypoglycemia per participant (54.1 and 59, respectively) compared with participants using aspart (78.2 and 127, respectively).
“TI’s rapid onset and ultra-short action provide insulin when needed at meals and between meals,” wrote the researchers.
For more information about the results of this study and its potential implications, Endocrinology Advisor sat down with David Kendall, MD, former chief scientific and medical officer for the American Diabetes Association.