Pulmonary Safety in Diabetics with T/I
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,053
Inhalation, 15U/30U
Subjects will receive antidiabetes treatment at the discretion of their physicians
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
Change from Baseline to End of Study in FEV1 by MMRM
Time frame: Baseline to Month 24
FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
FEV1 decrease of ≥ 15% from Baseline value at last measurement
Time frame: Baseline to Month 24
Change From Baseline to Last Measurement in FEV1 for TI vs Usual Care
Change from Baseline to last measurement(Month 24) in FEV1
Time frame: Baseline to Month 24
Change From Baseline to Month 24 in Forced Vital Capacity (FVC) by MMRM
Change from Baseline to Month 24 in FVC by MMRM
Time frame: Baseline to Month 24
Change From Baseline to Month 24 in Total Lung Capacity (TLC) by MMRM
Change from baseline to Month 24 in TLC by MMRM
Time frame: Baseline to Month 24
Change From Baseline to Month 24 in Hemoglobin Corrected DLco by MMRM
Change from baseline to Month 24 in hemoglobin-corrected DLco by MMRM
Time frame: Baseline to Month 24
Forced Vital Capacity (FVC) Decrease of ≥ 15% From Baseline Value at Last Measurement
FVC Decrease of ≥15% from Baseline Value at Last Measurement
Time frame: Baseline to Month 24
Total Lung Capacity (TLC) Decrease of ≥ 15% From Baseline Value at Last Measurement
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Southwest Health Ltd Research Division
Phoenix, Arizona, United States
Lovelace Scientific Resources
Phoenix, Arizona, United States
Northwest Medical Center
Phoenix, Arizona, United States
Arizona Center for Clinical Research
Phoenix, Arizona, United States
Premiere Pharmaceutical Research LLC
Tempe, Arizona, United States
Canyon Clinical Research
Tucson, Arizona, United States
Arizona Research Associates
Tuscon, Arizona, United States
Private Practice
Burlingame, California, United States
Saint Agnes Medical Center
Fresno, California, United States
Valley Research
Fresno, California, United States
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TLC Decrease of ≥ 15% from Baseline Value at Last Measurement
Time frame: Baseline to Month 24
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of ≥ 15% From Baseline Value at Last Measurement
Hemoglobin-corrected DLco decrease of ≥ 15% from baseline value at last measurement
Time frame: Baseline to Month 24
Hemoglobin-Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Decrease of >3 ml/Min/mmHg From Baseline Value at Last Measurement
Hemoglobin-corrected DLco decrease of \>3 ml/min/mmHg from baseline value at last measurement
Time frame: Baseline to Month 24
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Last Measurement for TI vs Usual Care
Change from baseline in HbA1c at last measurement
Time frame: Baseline to Month 24
Change in Weight From Baseline at Month 24
Change from baseline in weight at Month 24
Time frame: Baseline to Month 24