A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults With Type 1 Diabetes
Irl B. Hirsch, Roy W. Beck, Martin Chase Marak, Yogish C. Kudva, Halis Kaan Aktürk, Anuj Bhargava, Kevin Codorniz, Jamie Diner, Grazia Aleppo, Thomas Blevins, Carol J. Levy, Philip Raskin, Kristin Castorino, Anastasios Manessis, David Pickering, Devin Steenkamp, Ruth S. Weinstock, Bruce W. Bode, Osama Hamdy, Quang T. Nguyen, Mark Kipnes, Katrina J. Ruedy, Donna Desjardins, Zehra Haider, Christopher Jacobson, Scott Lee, John B. Buse, Klara R. Klein, Grenye O’Malley, Mei Mei Church, Adham Mottalib, Jesica D. Baran, Corey Kurek, Shafaq Rizvi, Cassandra Donahue, Denisa Tamarez, Astrid Atakov-Castillo, Sarah Borgman, Sarah Frey, Peter Calhoun, INHALE-3 Study Group, Bruce W. Bode, Jonathan G. Ownby, Joseph H. Johnson, Adriana Ruiz, Nashia Stephens, Amanda Maxson, Halis K. Akturk, Zehra Haider, Christie Beatson, E E Mason, Devin Steenkamp, Howard Wolpert, Astrid Atakov-Castillo, Asya Sullivan, Mark Kipnes, Amna Salhin, Tina Copple, Stephanie Beltran, Terri Ryan, Carol J. Levy, Grenye O’Malley, Camilla Levister, Denisa Tamarez, Aslihan Ipek, Anuj Bhargava, Christine Burke, Christine Langel, Shannon Bauman, Cristina Haight, A. Bohr, Osama Hamdy, Adham Mottalib, Tareq Salah, Marwa Al Badri, Shilton Dhaver, Quang T. Nguyen, Loida Nguyen, Kevin Codorniz, Scott Lee, Christopher Jacobson, Christian Cordero, Brittney Migliozzi, Yogish C. Kudva, Donna Desjardins, Corey Reid, Shafaq Rizvi, Ravinder Jeet Kaur, Daine Livingood, David Pickering, Dana Cruse, Grazia Aleppo, Jelena Kravarusic, Kasey Coyne, Stefanie Herrmann, Evelyn Fronczyk, Anastasios Manessis, Lorcan McKillop, Jamie Hyatt, Maria Patruno
Abstract
OBJECTIVE: To evaluate a regimen of inhaled Technosphere insulin (TI) plus insulin degludec in adults with type 1 diabetes, who prestudy were predominately using either an automated insulin delivery (AID) system or multiple daily insulin injections (MDI) with continuous glucose monitoring. RESEARCH DESIGN AND METHODS: At 19 sites, adults with type 1 diabetes were randomly assigned to TI plus insulin degludec (N = 62) or usual care (UC) with continuation of prestudy insulin delivery method (N = 61) for 17 weeks. RESULTS: Prestudy, AID was used by 48% and MDI by 45%. Mean ± SD HbA1c was 7.57% ± 0.97% at baseline and 7.62% ± 1.06% at 17 weeks in the TI group and 7.59% ± 0.80% and 7.54% ± 0.77%, respectively, in the UC group (adjusted difference 0.11%, 95% CI -0.10 to 0.33, P value for noninferiority = 0.01). HbA1c improved from baseline to 17 weeks by >0.5% (5.5 mmol/mol) in 12 (21%) in the TI group and in 3 (5%) in the UC group and worsened by >0.5% (5.5 mmol/mol) in 15 (26%) in the TI group and in 2 (3%) in the UC group. The most common TI side effect was a brief cough; eight participants discontinued TI due to side effects. CONCLUSIONS: In adults with type 1 diabetes, HbA1c after 17 weeks with a regimen of TI and degludec was noninferior to UC, which consisted predominately of either AID or MDI. TI should be considered an option for people with type 1 diabetes, particularly those who are motivated to further reduce postprandial hyperglycemia.