Diabetes Mellitus, Type 2
Conditions
Keywords
type 2 diabetes, insulin, glycemic control
Brief summary
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.
Interventions
Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetes Mellitus, Type 2 on oral agents * Age \> 30 years
Exclusion criteria
* Severe Asthma, severe Chronic Obstructive Pulmonary Disease * Smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 | Baseline, Week 26 | Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With HbA1c < 6.5 % | Week 26 | Number of subjects with glycemic control HbA1c measurement of \< 6.5 % at observation. |
| Number of Subjects With HbA1c < 7.0 % | Week 26 | Number of subjects with glycemic control HbA1c measurement of \< 7.0 % at observation. |
| Number of Subjects With HbA1c < 8.0 % | Week 26 | Number of subjects with glycemic control HbA1c measurement of \< 8.0 % at observation. |
| Change From Baseline in Fasting Plasma Glucose (FPG) Level | Baseline, Week 26 | FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline. |
| Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Baseline, Week 26 | Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal. |
| Number of Subjects With Hypoglycemic Events by Severity | Week 26 | Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose \<=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate. |
| Number of Events of Nocturnal Hypoglycemia | Week 26 | Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose \<3.27 mmol/L (59 mg/dL); or any glucose measurement \<=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized. |
| Change From Baseline in Body Weight | Baseline, Week 26 | Change from baseline calculated as body weight at observation minus body weight at baseline. |
| Change From Baseline in HbA1c Prior to Week 26 | Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18 | Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline. |
| Number of Subjects Discontinued Due to Insufficient Clinical Response | Week 26 | Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c \> 12.0 % or frequent and unexplained severe hypoglycemic events (\> 3 events per month for 2 or more months); subject's HbA1c not \< = 7 % at Week 12. |
| Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health | Week 26 | Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program. |
| Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients | Baseline, Week 26 | The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3. |
| Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP) | Baseline, Week 26 | Change from baseline in CV biomarker hs-CRP (milligrams per deciliter \[mg/dl\]) calculated as hs-CRP at observation minus hs-CRP at baseline. |
| Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6) | Baseline, Week 26 | Change from baseline in IL-6 (picograms per milliliter \[pg/ml\]) calculated as IL-6 at observation minus IL-6 at baseline. |
| Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes) | Baseline, Week 26 | Change from baseline in tat-complexes (nanograms per milliliter \[ng/ml\]) calculated as tat-complexes at observation minus tat-complexes at baseline. |
| Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF) | Baseline, Week 26 | Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline. |
| Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects | Baseline, Week 26 | Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program. |
| Change From Baseline in Body Mass Index (BMI) | Baseline, Week 26 | BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline. |
Countries
Belgium, Finland, France, Germany, Netherlands, Norway, Poland, Spain, Sweden, Switzerland
Participant flow
Pre-assignment details
Number of subjects randomized = 261; number of subjects treated (out of 261 randomized) = 257.
Participants by arm
| Arm | Count |
|---|---|
| Inhaled Human Insulin (Exubera®) Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification. | 135 |
| Insulin Glargine (Lantus®) Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification. | 122 |
| Total | 257 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 8 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Other | 4 | 3 |
| Overall Study | Withdrawal by Subject | 10 | 1 |
Baseline characteristics
| Characteristic | Inhaled Human Insulin (Exubera®) | Insulin Glargine (Lantus®) | Total |
|---|---|---|---|
| Age, Customized 18 - 44 years | 8 participants | 3 participants | 11 participants |
| Age, Customized 45 - 64 years | 78 participants | 71 participants | 149 participants |
| Age, Customized > = 65 years | 49 participants | 48 participants | 97 participants |
| Sex: Female, Male Female | 54 Participants | 51 Participants | 105 Participants |
| Sex: Female, Male Male | 81 Participants | 71 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 105 / 135 | 81 / 122 |
| serious Total, serious adverse events | 8 / 135 | 10 / 122 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.
Time frame: Baseline, Week 26
Population: Full analysis set (FAS) all randomized subjects with at least 1 dose of study medication, baseline and post-baseline HbA1c measurement. Last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 | -1.7 percent | Standard Deviation 1.19 |
| Insulin Glargine (Lantus®) | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 | -1.4 percent | Standard Deviation 1.14 |
Secondary
Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)
Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.
Time frame: Baseline, Week 26
Population: FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Average overall absolute BG (n=101, 95) | -45.0 mg/dl | Standard Deviation 46.26 |
| Inhaled Human Insulin (Exubera®) | Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Average pre-meal BG (n=101, 95) | -38.1 mg/dl | Standard Deviation 43.24 |
| Inhaled Human Insulin (Exubera®) | Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Average post-meal BG (n=99, 91) | -64.5 mg/dl | Standard Deviation 59.35 |
| Inhaled Human Insulin (Exubera®) | Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Change from pre-meal to post-meal BG (n=99, 91) | -24.5 mg/dl | Standard Deviation 35.28 |
| Insulin Glargine (Lantus®) | Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Change from pre-meal to post-meal BG (n=99, 91) | 1.6 mg/dl | Standard Deviation 39.82 |
| Insulin Glargine (Lantus®) | Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Average overall absolute BG (n=101, 95) | -43.7 mg/dl | Standard Deviation 48.41 |
| Insulin Glargine (Lantus®) | Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Average post-meal BG (n=99, 91) | -49.6 mg/dl | Standard Deviation 58.33 |
| Insulin Glargine (Lantus®) | Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) | Average pre-meal BG (n=101, 95) | -50.7 mg/dl | Standard Deviation 47.54 |
Secondary
Change From Baseline in Body Mass Index (BMI)
BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.
Time frame: Baseline, Week 26
Population: FAS; LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in Body Mass Index (BMI) | 0.7 kg/m2 | Standard Deviation 1.24 |
| Insulin Glargine (Lantus®) | Change From Baseline in Body Mass Index (BMI) | 0.4 kg/m2 | Standard Deviation 1.2 |
Secondary
Change From Baseline in Body Weight
Change from baseline calculated as body weight at observation minus body weight at baseline.
Time frame: Baseline, Week 26
Population: FAS; LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in Body Weight | 2.2 kilograms (kg) | Standard Deviation 3.57 |
| Insulin Glargine (Lantus®) | Change From Baseline in Body Weight | 1.1 kilograms (kg) | Standard Deviation 3.43 |
Secondary
Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)
Change from baseline in CV biomarker hs-CRP (milligrams per deciliter \[mg/dl\]) calculated as hs-CRP at observation minus hs-CRP at baseline.
Time frame: Baseline, Week 26
Population: FAS; LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP) | 0.2 mg/dl | Standard Deviation 1.92 |
| Insulin Glargine (Lantus®) | Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP) | -0.1 mg/dl | Standard Deviation 1.56 |
Secondary
Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)
Change from baseline in IL-6 (picograms per milliliter \[pg/ml\]) calculated as IL-6 at observation minus IL-6 at baseline.
Time frame: Baseline, Week 26
Population: FAS; LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6) | -1.1 pg/ml | Standard Deviation 4.05 |
| Insulin Glargine (Lantus®) | Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6) | -2.4 pg/ml | Standard Deviation 10.41 |
Secondary
Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)
Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.
Time frame: Baseline, Week 26
Population: FAS; LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF) | 230.2 pg/ml | Standard Deviation 279.92 |
| Insulin Glargine (Lantus®) | Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF) | 170.4 pg/ml | Standard Deviation 174.07 |
Secondary
Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)
Change from baseline in tat-complexes (nanograms per milliliter \[ng/ml\]) calculated as tat-complexes at observation minus tat-complexes at baseline.
Time frame: Baseline, Week 26
Population: FAS; LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes) | -3.4 ng/ml | Standard Deviation 10 |
| Insulin Glargine (Lantus®) | Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes) | -40.4 ng/ml | Standard Deviation 166.9 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) Level
FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.
Time frame: Baseline, Week 26
Population: FAS; LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in Fasting Plasma Glucose (FPG) Level | -30.6 mg/dl | Standard Deviation 49.04 |
| Insulin Glargine (Lantus®) | Change From Baseline in Fasting Plasma Glucose (FPG) Level | -60.1 mg/dl | Standard Deviation 51.95 |
Secondary
Change From Baseline in HbA1c Prior to Week 26
Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18
Population: FAS; LOCF; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Change From Baseline in HbA1c Prior to Week 26 | Week 4 (n = 134, 121) | -0.8 percent | Standard Deviation 0.61 |
| Inhaled Human Insulin (Exubera®) | Change From Baseline in HbA1c Prior to Week 26 | Week 12 (n = 134, 121) | -1.6 percent | Standard Deviation 1.08 |
| Inhaled Human Insulin (Exubera®) | Change From Baseline in HbA1c Prior to Week 26 | Week 8 (n = 134, 121) | -1.3 percent | Standard Deviation 0.86 |
| Inhaled Human Insulin (Exubera®) | Change From Baseline in HbA1c Prior to Week 26 | Week 18 (n = 134, 121) | -1.7 percent | Standard Deviation 1.16 |
| Inhaled Human Insulin (Exubera®) | Change From Baseline in HbA1c Prior to Week 26 | Week 2 (n = 128, 108) | -0.4 percent | Standard Deviation 0.4 |
| Insulin Glargine (Lantus®) | Change From Baseline in HbA1c Prior to Week 26 | Week 18 (n = 134, 121) | -1.5 percent | Standard Deviation 1.11 |
| Insulin Glargine (Lantus®) | Change From Baseline in HbA1c Prior to Week 26 | Week 2 (n = 128, 108) | -0.3 percent | Standard Deviation 0.4 |
| Insulin Glargine (Lantus®) | Change From Baseline in HbA1c Prior to Week 26 | Week 4 (n = 134, 121) | -0.6 percent | Standard Deviation 0.58 |
| Insulin Glargine (Lantus®) | Change From Baseline in HbA1c Prior to Week 26 | Week 8 (n = 134, 121) | -1.1 percent | Standard Deviation 0.85 |
| Insulin Glargine (Lantus®) | Change From Baseline in HbA1c Prior to Week 26 | Week 12 (n = 134, 121) | -1.3 percent | Standard Deviation 0.99 |
Secondary
Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health
Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program.
Time frame: Week 26
Secondary
Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects
Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program.
Time frame: Baseline, Week 26
Secondary
Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients
The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.
Time frame: Baseline, Week 26
Population: FAS; (n) = number of subjects with analyzable data at observation for inhaled insulin and insulin glargine, respectively. Revised table rectifies a programming code error that was determined post-Clinical study report (CSR) approval.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients | Week 26: 24-hour mean (n=14, 12) | 107.6 mg/dl | Standard Deviation 18.46 |
| Inhaled Human Insulin (Exubera®) | Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients | Week 26: 24-hour SD (n=14, 12) | 33.7 mg/dl | Standard Deviation 17.22 |
| Insulin Glargine (Lantus®) | Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients | Week 26: 24-hour mean (n=14, 12) | 102.1 mg/dl | Standard Deviation 18.02 |
| Insulin Glargine (Lantus®) | Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients | Week 26: 24-hour SD (n=14, 12) | 30.7 mg/dl | Standard Deviation 8.09 |
Secondary
Number of Events of Nocturnal Hypoglycemia
Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose \<3.27 mmol/L (59 mg/dL); or any glucose measurement \<=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.
Time frame: Week 26
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inhaled Human Insulin (Exubera®) | Number of Events of Nocturnal Hypoglycemia | 159 events |
| Insulin Glargine (Lantus®) | Number of Events of Nocturnal Hypoglycemia | 81 events |
Secondary
Number of Subjects Discontinued Due to Insufficient Clinical Response
Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c \> 12.0 % or frequent and unexplained severe hypoglycemic events (\> 3 events per month for 2 or more months); subject's HbA1c not \< = 7 % at Week 12.
Time frame: Week 26
Population: Safety population: all subjects who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inhaled Human Insulin (Exubera®) | Number of Subjects Discontinued Due to Insufficient Clinical Response | 3 participants |
| Insulin Glargine (Lantus®) | Number of Subjects Discontinued Due to Insufficient Clinical Response | 0 participants |
Secondary
Number of Subjects With HbA1c < 6.5 %
Number of subjects with glycemic control HbA1c measurement of \< 6.5 % at observation.
Time frame: Week 26
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inhaled Human Insulin (Exubera®) | Number of Subjects With HbA1c < 6.5 % | 37 participants |
| Insulin Glargine (Lantus®) | Number of Subjects With HbA1c < 6.5 % | 23 participants |
Secondary
Number of Subjects With HbA1c < 7.0 %
Number of subjects with glycemic control HbA1c measurement of \< 7.0 % at observation.
Time frame: Week 26
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inhaled Human Insulin (Exubera®) | Number of Subjects With HbA1c < 7.0 % | 84 participants |
| Insulin Glargine (Lantus®) | Number of Subjects With HbA1c < 7.0 % | 67 participants |
Secondary
Number of Subjects With HbA1c < 8.0 %
Number of subjects with glycemic control HbA1c measurement of \< 8.0 % at observation.
Time frame: Week 26
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Inhaled Human Insulin (Exubera®) | Number of Subjects With HbA1c < 8.0 % | 121 participants |
| Insulin Glargine (Lantus®) | Number of Subjects With HbA1c < 8.0 % | 108 participants |
Secondary
Number of Subjects With Hypoglycemic Events by Severity
Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose \<=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.
Time frame: Week 26
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Number of Subjects With Hypoglycemic Events by Severity | Week 26 Mild, Moderate | 26 participants |
| Inhaled Human Insulin (Exubera®) | Number of Subjects With Hypoglycemic Events by Severity | Week 26 Severe | 1 participants |
| Insulin Glargine (Lantus®) | Number of Subjects With Hypoglycemic Events by Severity | Week 26 Mild, Moderate | 32 participants |
| Insulin Glargine (Lantus®) | Number of Subjects With Hypoglycemic Events by Severity | Week 26 Severe | 1 participants |