Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents
Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin
Unnamed facility
Mission Hills, California, United States
Unnamed facility
San Diego, California, United States
Change in Post-bronchodilator FEV1 From Baseline to Week 52
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.
Time frame: 52 Weeks
Number of Participants With Asthma Exacerbation by Treatment Arm
Number of participants who experienced worsening of asthma symptoms
Time frame: Baseline to Week 52
Number of Participants With COPD Exacerbation by Treatment Arm
Number of participants who experienced worsening of COPD symptoms
Time frame: Baseline to Week 52
Change in HbA1C From Baseline to Week 52
Time frame: Baseline, week 52
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Unnamed facility
Palm Harbor, Florida, United States
Unnamed facility
Flint, Michigan, United States
Unnamed facility
Morehead City, North Carolina, United States
Unnamed facility
Medford, Oregon, United States
Unnamed facility
Greenville, South Carolina, United States
Unnamed facility
Spartanburg, South Carolina, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Dallas, Texas, United States
...and 11 more locations