| Primary | Change From Baseline to Week 24 in HbA1c | Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24 | | Posted | | Least Squares Mean | Standard Error | percentage of hemoglobin | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.82± 0.061
- OG001-0.42± 0.062
|
|
| | 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 |
|---|
| | Mixed Models Analysis | Change in HbA1c = Baseline HbA1c + Region + Pooled OAD Strata + Visit + Treatment + (Treatment*Visit), using AR(1) variance/covariance structure. | <0.0001 | | Mean Difference (Final Values) | -0.40 | | | 2-Sided | 95 | -0.57 | -0.23 | | | | No | Superiority or Other | | |
|
| Secondary | Proportion of Responders Achieving HbA1c <= 7.0% | Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0% | Full analysis set for subjects with available data at Week 24 | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Proportion of Responders Achieving HbA1c <= 6.5% | Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% at Week 24 | Full analysis set for subjects with available data at Week 24 | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | FPG Change From Baseline to Week 24 | Efficacy as measured by mean change in fasting plasma glucose (FPG) | Full analysis set for subjects with data at both Baseline and at Week 24 | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Proportion of Subjects Requiring Rescue Therapy | | | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Time to Rescue | Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment | | Posted | | Median | Full Range | Days | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | FEV1 Change From Baseline to Week 24 | Forced Expiratory Volume in 1 second - change from baseline to week 24 | Full analysis set for patients with data at both Baseline and at Week 24 | Posted | | Mean | Standard Deviation | Liters | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Incidence of Total Hypoglycemia | Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates. | | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Incidence of Severe Hypoglycemia | Severe Hypoglycemia defined as: Requiring 3rd party assistance. | | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Total Hypoglycemia Event Rate | Number of Hypoglycemic Events/Total Subject Exposure Time (in months) | | Posted | | Number | | Events/Subject-Month | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Severe Hypoglycemia Event Rate | Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months) | | Posted | | Number | | Events/100 Subject-Month | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Mean 7-point Glucose Baseline Values | Mean 7-point self-monitored glucose at baseline | | Posted | | Mean | Standard Deviation | mg/dL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Mean 7-point Glucose Week 24 Values | Mean 7-point self-monitored blood glucose at Week 24 | Full analysis set for patients with data at Week 24 | Posted | | Mean | Standard Deviation | mg/dL | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |
| Secondary | Change in Body Weight From Baseline to Week 24 | Change in body weight from Baseline to Week 24 | Full analysis set for patients with data at both Baseline and at Week 24 | Posted | | Least Squares Mean | Standard Error | kg | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TI Inhalation Powder + OADs | Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient | | OG001 | Technosphere Powder | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient |
| |