A Randomized Trial Comparing Inhaled Insulin Plus Basal Insulin Versus Usual Care in Adults With Type 1 Diabetes
Authors: Hirsch Irl B. , Beck Roy W. , Marak Martin C. , Kudva Yogish , Akturk Halis K. , Bhargava Anuj , Codorniz Kevin , Diner Jamie , Aleppo Grazia , Blevins Thomas , Levy Carol J. , Raskin Philip , Castorino Kristin , Manessis Anastasios , Pickering David , Steenkamp Devin W. , Weinstock Ruth S. , Bode Bruce W. , Hamdy Osama , Nguyen Quang T. , Kipnes Mark , Ruedy Katrina J. , Desjardins Donna , Haider Zehra , Jacobson Christopher , Lee Scott , Buse John B. , Klein Klara Rachel , O’Malley Grenye , Church Mei Mei , Mottalib Adham , Baran Jesica D. , Kurek Corey , Rizvi Shafaq , Donahue Cassandra , Tamarez Denisa , Atakov Castillo Astrid , Borgman Sarah , Frey Sarah , Calhoun Peter ,   INHALE-3 Study Group, Bode Bruce W. , Ownby Jonathan , Johnson Joseph , Ruiz Adriana , Stephens Nashia , Maxson Amanda , Akturk Halis K. , Haider Zehra , Beatson Christie , Mason Emma , Steenkamp Devin W. , Wolpert Howard , Atakov-Castillo Astrid , Sullivan Asya , Kipnes Mark , Salhin Amna , Copple Tina , Beltran Stephanie , Ryan Terri , Levy Carol J. , O’Malley Grenye , Levister Camilla , Tamarez Denisa , Ipek Aslihan , Bhargava Anuj , Burke Christine , Langel Christine , Bauman Shannon , Haight Cristina , Bohr Allie , Hamdy Osama , Mottalib Adham , Salah Tareq , Al Badri Marwa , Dhaver Shilton , Nguyen Quang T. , Nguyen Loida , Codorniz Kevin , Lee Scott , Jacobson Christopher , Cordero Christian , Migliozzi Brittney , Kudva Yogish , Desjardins Donna , Reid Corey , Rizvi Shafaq , Kaur Ravinder Jeet , Livingood Daine , Pickering David , Cruse Dana , Aleppo Grazia , Kravarusic Jelena , Coyne Kasey , Herrmann Stefanie , Fronczyk Evelyn , Manessis Anastasios , McKillop Lorcan , Hyatt Jamie , Patruno Maria , Castorino Kristin , Church Mei Mei , Thorsell Ashley , Shuirman Maggie , Cobb Brandon , Watt Olivia , Weinstock Ruth , Bzdick Suzan , Blevins Thomas , Casaubon Luis , Espinosa Valerie , Pandit Keta , Perez Jennifer , Armstrong Chloe , Martinez-Arredondo Maritza , Stewart Ana , Johnson Olivia , Diner Jamie , Buse John , Klein Klara , Ghorbani Tahereh , Young Laura , Coviello Andrea D. , Donahue Cassandra , Kass Alexander , Fulghum Karla , Raskin Philip , Jordan Lin , Shao Baomei , Hirsch Irl B. , Baran Jesica , Mandava Patali , Holod Rosanna , Kaiserman Kevin , Ulloa Johanna , Pleitez Jennifer , Sylvan Joey , Badgett Lynn , Ruedy Katrina , Beck Roy , Borgman Sarah , Frey Sarah , Mba-Oduwusi Nnenna , Miller Paige , Fults Ashleigh , Marak Martin Chase , Calhoun Peter , Pritchard Rosa , Dolzhenko Elizaveta , McCarthy Chris , Gabrielson Deanna , Brown Sue , Ahmann Andrew , Bergenstal Richard 
Published: December 2024

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 &gt;0.5% (5.5 mmol/mol) in 12 (21%) in the TI group and in 3 (5%) in the UC group and worsened by &gt;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.