| Primary | Change in HbA1c (%) From Baseline to Week 16 | Change from Baseline in glycated hemoglobin at Week 16 | Safety Population, participants with data available at Baseline and Week 16 | Posted | | Least Squares Mean | Standard Deviation | Percentage of total hemoglobin | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.2179± 0.1468
- OG001-1.2652± 0.1571
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate | ANCOVA | | 0.8283 | | Mean Difference (Final Values) | -0.0473 | Standard Error of the Mean | 0.2158 | 2-Sided | 95 | -0.4901 | 0.3956 | | | | Yes | Non-Inferiority or Equivalence | Study terminated early due to business reasons, results are not properly powered. | |
|
| Secondary | To Evaluate the Effect of Each Treatment on HbA1c | Not analyzed due to early termination of the trial. | | Not Posted | | | | | | Change from baseline to 16 weeks | | | | | | |
| Secondary | Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study | Not analyzed due to early termination of the trial. | | Not Posted | | | | | | Change from baseline to 16 weeks | | | | | | |
| Secondary | Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study | Not analyzed due to early termination of the trial. | | Not Posted | | | | | | Change from baseline to 16 weeks | | | | | | |
| Secondary | Glycomark and Fructosamine Levels Measured Throughout the Study | Not analyzed due to early termination of the trial. | | Not Posted | | | | | | Change from baseline to 16 weeks | | | | | | |
| Secondary | Seven-point Glucose at Randomization and Throughout the Study | Not analyzed due to early termination of the trial. | | Not Posted | | | | | | Change from baseline to 16 weeks | | | | | | |
| Secondary | Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM) | Not analyzed due to early termination of the trial. | | Not Posted | | | | | | Change from baseline to 16 weeks | | | | | | |
| Secondary | Changes in Body Weight at 16 Weeks | Not analyzed due to early termination of the trial. | | Not Posted | | | | | | Change from baseline to 16 weeks | | | | | | |
| Secondary | Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires | Not analyzed due to early termination of the trial. | | Not Posted | | | | | | Change from baseline to 16 weeks | | | | | | |
| Secondary | Total Number of Cough Episodes | Total number of times patients coughed once, intermittently or continuously (inclusive) | | Posted | | Number | | Cough episodes | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | 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
| | Posted | | Number | | Events / subject-month | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | 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
| | Posted | | Number | | Events / subject-month | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere® Insulin Inhalation Powder (TI) | Insulin Glargine and Technosphere® Insulin Inhalation Powder Technosphere® Insulin Inhalation Powder Insulin Glargine | | OG001 | Comparator | Insulin Glargine and Insulin Aspart Insulin Aspart: Usual Care Insulin Glargine |
| |
| Secondary | Number of Subjects Reporting Cough Episodes | Number of Subjects Reporting Cough Episodes | | Posted | | Number | | Number of participants | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Number of Subjects Reporting Intermittent Coughing Episodes | Number of subjects reporting Intermittent Coughing Episodes | | Posted | | Number | | Number of participants | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Number of Single Coughing Episodes | Total number of times patients coughed only once | | Posted | | Number | | Cough episodes | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation | | | Posted | | Number | | Cough episodes | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Baseline Forced Expiratory Volume in 1 Second (FEV1) | | | Posted | | Mean | Standard Deviation | L | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Week 16 Forced Expiratory Volume in 1 Second | | Safety Population, with data available at Week 16 | Posted | | Mean | Standard Deviation | L | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second | Week 16 Change from Baseline in FEV1 | Safety Population, with data available at Week 16 | Posted | | Mean | Standard Deviation | L | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Week 20 (Follow-up) Forced Expiratory Volume in 1 Second | Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment | Safety Population, with data available at Week 20 | Posted | | Mean | Standard Deviation | L | | Week 20 (Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | 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 | Safety Population, with data available at Week 20 | Posted | | Mean | Standard Deviation | L | | Baseline to Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Baseline Forced Vital Capacity (FVC) | | | Posted | | Mean | Standard Deviation | L | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Week 16 Forced Vital Capacity | | Safety Population, with data available at Week 16 | Posted | | Mean | Standard Deviation | L | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Week 16 Change From Baseline Forced Vital Capacity | Week 16 Change from Baseline FVC | Safety Population, with data available at Week 16 | Posted | | Mean | Standard Deviation | L | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | Week 20 (Follow-up) Forced Vital Capacity | Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC | Safety Population, with data available at Week 20 | Posted | | Mean | Standard Deviation | L | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |
| Secondary | 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 | Safety Population, with data available at Week 20 | Posted | | Mean | Standard Deviation | L | | Baseline to Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Technosphere Insulin + Insulin Glargine | Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient | | OG001 | Insulin Aspart + Insulin Glargine | Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient |
| |