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This protocol was terminated not for safety reasons, but because Pfizer decided to return the worldwide rights for Exubera to Nektar, on 18 October 2007.
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The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator |
| |
| Experimental | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Human Insulin (Exubera) | Drug | Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline | Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16 | From baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF) | Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hong Kong | Hong Kong | ||||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study before it had recruited targeted number of subjects and followed them for the per protocol specified period.
Five centers in the Philippines, 2 centers in Singapore, 1 center in Hong Kong, and 1 center in Pakistan enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exubera Dose of 1mg Three Times Daily (TID) | Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner) |
| FG001 | Exubera Dose (mg) as Per Weight Based Formula TID |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Inhaled Human Insulin (Exubera) | Drug | Initial dose of 1mg TID of inhaled human insulin |
|
| From baseline to week 16 |
| Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia | Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms. | week 16 |
| Hypoglycemia Event Rate Per Month | Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16). | up to week 4 or 16 |
| Karachi |
| Sindh |
| 74600 |
| Pakistan |
| Pfizer Investigational Site | Makati | 1218 | Philippines |
| Pfizer Investigational Site | Marikina City | 1810 | Philippines |
| Pfizer Investigational Site | Pasay | 1300 | Philippines |
| Pfizer Investigational Site | Pasig | 1605 | Philippines |
| Pfizer Investigational Site | Quezon City | 1102 | Philippines |
| Pfizer Investigational Site | Singapore | 119074 | Singapore |
| Pfizer Investigational Site | Singapore | 159964 | Singapore |
Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exubera Dose of 1mg Three Times Daily (TID) | Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner) |
| BG001 | Exubera Dose (mg) as Per Weight Based Formula TID | Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF) | Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values. | FAS - descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data. | Posted | Mean | Standard Deviation | mmol/l | From baseline to week 16 |
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| Primary | Change in HbA1c From Baseline | Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16 | Full analysis set (FAS) population - descriptive statistics were produced using last observation carried forward (LOCF) for Week 16, therefore all subjects are included in the Week 16 data. | Posted | Mean | Standard Deviation | Percent | From baseline to week 16 |
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| Secondary | Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia | Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms. | FAS Population - Descriptive statistics were produced using LOCF for Week 16, therefore all subjects are included in the Week 16 data. | Posted | Number | participants | week 16 |
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| Secondary | Hypoglycemia Event Rate Per Month | Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16). | FAS Population | Posted | Mean | Standard Deviation | event rate per month | up to week 4 or 16 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exubera Dose of 1mg Three Times Daily (TID) | Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner) | 2 | 17 | ||||
| EG001 | Exubera Dose (mg) as Per Weight Based Formula TID | Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID. | 0 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure inadequately controlled | Vascular disorders | MedDRA v11.1 | Systematic Assessment |
| |
| Pelvic Instability at the Lumbar Spine | Musculoskeletal and connective tissue disorders | NedDRA v11.1 | Systematic Assessment |
| |
| Diabetic Neuropathy | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorders | Eye disorders | MedDRA v10.1 | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MdeDRA v10.1 | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | MedDRA v10.1 | Systematic Assessment |
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| Infections and infestations | Infections and infestations | MedDRA v10.1 | Systematic Assessment |
| |
| Metabolism and nutrition discorders | Metabolism and nutrition disorders | MedDRA v10.1 | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | MedDRA v10.1 | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA v10.1 | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA v10.1 | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA v10.1 | Systematic Assessment |
|
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera (insulin human [rDNA origin]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C473734 | Exubera |
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| Title | Measurements |
|---|---|
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| 45 - 64 years |
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| >= 65 years |
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| Male |
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| Pre-meal blood glucose |
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| Post-meal blood glucose |
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| Change from pre-meal to post-meal blood glucose |
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