| Outcome Measures: |
Primary: Change in HbA1c (%) From Baseline to Week 16, Change from Baseline in glycated hemoglobin at Week 16, Baseline to Week 16 | Secondary: To Evaluate the Effect of Each Treatment on HbA1c, Not analyzed due to early termination of the trial., Change from baseline to 16 weeks|Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study, Not analyzed due to early termination of the trial., Change from baseline to 16 weeks|Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study, Not analyzed due to early termination of the trial., Change from baseline to 16 weeks|Glycomark and Fructosamine Levels Measured Throughout the Study, Not analyzed due to early termination of the trial., Change from baseline to 16 weeks|Seven-point Glucose at Randomization and Throughout the Study, Not analyzed due to early termination of the trial., Change from baseline to 16 weeks|Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM), Not analyzed due to early termination of the trial., Change from baseline to 16 weeks|Changes in Body Weight at 16 Weeks, Not analyzed due to early termination of the trial., Change from baseline to 16 weeks|Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires, Not analyzed due to early termination of the trial., Change from baseline to 16 weeks|Total Number of Cough Episodes, Total number of times patients coughed once, intermittently or continuously (inclusive), Baseline to Week 16|Severe Hypoglycemic Event Rate, Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either: * SMBG levels ≤ 36 mg/dL OR * There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures, Baseline to Week 16|Mild or Moderate Hypoglycemic Event Rate, Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation Nonsevere hypoglycemia is defined as a subject: * SMBG levels \< 70 mg/dL AND/OR * Symptoms that are relieved by the self-administration of carbohydrates, Baseline to Week 16|Number of Subjects Reporting Cough Episodes, Number of Subjects Reporting Cough Episodes, Baseline to Week 16|Number of Subjects Reporting Intermittent Coughing Episodes, Number of subjects reporting Intermittent Coughing Episodes, Baseline to Week 16|Number of Single Coughing Episodes, Total number of times patients coughed only once, Baseline to Week 16|Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation, Baseline to Week 16|Baseline Forced Expiratory Volume in 1 Second (FEV1), Baseline FEV1, Baseline|Week 16 Forced Expiratory Volume in 1 Second, Week 16 FEV1, Week 16|Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second, Week 16 Change from Baseline in FEV1, Baseline to Week 16|Week 20 (Follow-up) Forced Expiratory Volume in 1 Second, Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment, Week 20 (Follow-up)|Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second, Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1, Baseline to Week 20|Baseline Forced Vital Capacity (FVC), Baseline FVC, Baseline|Week 16 Forced Vital Capacity, Week 16 FVC, Week 16|Week 16 Change From Baseline Forced Vital Capacity, Week 16 Change from Baseline FVC, Baseline to Week 16|Week 20 (Follow-up) Forced Vital Capacity, Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC, Week 20|Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity, Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC, Baseline to Week 20
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| Locations: |
Coastal Clinical Research Inc, Mobile, Alabama, 36608, United States|Valley Research, Fresno, California, 93720, United States|Health Care Partners Medical Group, Long Beach, California, 90806, United States|Diabetes Research Center, Tustin, California, 92780, United States|Diablo Clinical Research, Walnut Creek, California, 94598, United States|Laureate Clinical Research Group, Atlanta, Georgia, 30308, United States|Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States|Alta Pharmaceutical Research Center, Dunwoody, Georgia, 30338, United States|John H Stoger Jr Hospital of Cook County, Chicago, Illinois, 60612, United States|LaPorte County Institute for Clinical Research Inc., Michigan City, Indiana, 46360, United States|Radiant Research Inc (Minneapolis), Edina, Minnesota, 55435, United States|Amin Radparvar's Private Practice, St Peters, Missouri, 63376, United States|Washington University School of Medicine, St. Louis, Missouri, 63110, United States|Billings Clinic Research Center, Billings, Montana, 59101, United States|Creighton Diabetes Center, Omaha, Nebraska, 68131, United States|University of New Mexico HCS, Albuquerque, New Mexico, 87131, United States|Winthrop University Hospital, Mineola, New York, 11501, United States|North Shore Diabetes and Endocrine Associates, New Hyde Park, New York, 11042, United States|Endocrine Research Physicians East PA, Greenville, North Carolina, 27834, United States|Your Diabetes Endocrine Nutrition Group, Inc., Mentor, Ohio, 44060, United States|Legacy Clinical Research, Portland, Oregon, 97232, United States|OHSU Diabetes Center Research Oregon Health & Science University, Portland, Oregon, 97239, United States|The Endocrine Clinic, Memphis, Tennessee, 38119, United States|Dallas Diabetes & Endocrine Center, Dallas, Texas, 75230, United States|Baylor Endocrine Center, Dallas, Texas, 75246, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States|SAM Clinical Research Center, San Antonio, Texas, 78229, United States|Exodus Healthcare Network, Magna, Utah, 84044, United States|Diabetes Research Center -Fletcher Allen Health Care, South Burlington, Vermont, 05403, United States
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