This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.
Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 diabetes who are suboptimally controlled with their current insulin regimens.This trial will employ a variety of methods to intensively manage these subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Change in HbA1c (%) From Baseline to Week 16
Change from Baseline in glycated hemoglobin at Week 16
Time frame: Baseline to Week 16
To Evaluate the Effect of Each Treatment on HbA1c
Not analyzed due to early termination of the trial.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 16 weeks
Glycomark and Fructosamine Levels Measured Throughout the Study
Not analyzed due to early termination of the trial.
Time frame: Change from baseline to 16 weeks
Seven-point Glucose at Randomization and Throughout the Study
Not analyzed due to early termination of the trial.
Time frame: 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.
Time frame: Change from baseline to 16 weeks
Changes in Body Weight at 16 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Coastal Clinical Research Inc
Mobile, Alabama, United States
Valley Research
Fresno, California, United States
Health Care Partners Medical Group
Long Beach, California, United States
Diabetes Research Center
Tustin, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Laureate Clinical Research Group
Atlanta, Georgia, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Alta Pharmaceutical Research Center
Dunwoody, Georgia, United States
John H Stoger Jr Hospital of Cook County
Chicago, Illinois, United States
LaPorte County Institute for Clinical Research Inc.
Michigan City, Indiana, United States
...and 19 more locations
Not analyzed due to early termination of the trial.
Time frame: 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.
Time frame: Change from baseline to 16 weeks
Total Number of Cough Episodes
Total number of times patients coughed once, intermittently or continuously (inclusive)
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 16
Number of Subjects Reporting Cough Episodes
Number of Subjects Reporting Cough Episodes
Time frame: Baseline to Week 16
Number of Subjects Reporting Intermittent Coughing Episodes
Number of subjects reporting Intermittent Coughing Episodes
Time frame: Baseline to Week 16
Number of Single Coughing Episodes
Total number of times patients coughed only once
Time frame: Baseline to Week 16
Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation
Time frame: Baseline to Week 16
Baseline Forced Expiratory Volume in 1 Second (FEV1)
Baseline FEV1
Time frame: Baseline
Week 16 Forced Expiratory Volume in 1 Second
Week 16 FEV1
Time frame: Week 16
Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second
Week 16 Change from Baseline in FEV1
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 20
Baseline Forced Vital Capacity (FVC)
Baseline FVC
Time frame: Baseline
Week 16 Forced Vital Capacity
Week 16 FVC
Time frame: Week 16
Week 16 Change From Baseline Forced Vital Capacity
Week 16 Change from Baseline FVC
Time frame: Baseline to Week 16
Week 20 (Follow-up) Forced Vital Capacity
Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC
Time frame: 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
Time frame: Baseline to Week 20