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See termination reason in detailed description.
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To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus
Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera®, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera®. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator |
| |
| Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Human Insulin (Exubera®) | Drug | Preprandial inhaled insulin regimen and administration of insulin glargine QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) | 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. No efficacy data were summarized due to limited enrollment/early termination. | At 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8% | 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. No efficacy data were summarized due to limited enrollment/early termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire | 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. No efficacy data were summarized due to limited enrollment/early termination. |
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 | Hamilton | New Jersey | 08610 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
A total of 340 subjects were planned to be randomized; 87 were screened and 58 were randomized to study treatment prior to study termination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exubera ® | Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine. |
| FG001 | Insulin Lispro | Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Insulin lispro (Humalog) | Drug | Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD. |
|
| At 52 weeks |
| Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0% | 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. No efficacy data were summarized due to limited enrollment/early termination. | At 52 weeks |
| Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline | 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. No efficacy data were summarized due to limited enrollment/early termination. | At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation. |
| Change From Baseline in FPG | 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. No efficacy data were summarized due to limited enrollment/early termination. | At 52 weeks or last observation |
| Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments | 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. No efficacy data were summarized due to limited enrollment/early termination. | To 52 weeks |
| Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments | 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. No efficacy data were summarized due to limited enrollment/early termination. | To 52 weeks |
| Change From Baseline in Insulin Antibody Levels | 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. No efficacy data were summarized due to limited enrollment/early termination. | At weeks 24 and 52 or last observation. |
| Change From Baseline in Body Weight | 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. No efficacy data were summarized due to limited enrollment/early termination. | At weeks 12, 24, 36, and 52 or last observation. |
| Change From Baseline in Body Mass Index | 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. No efficacy data were summarized due to limited enrollment/early termination. | At weeks 12, 24, 36, and 52 or last observation. |
| Change From Baseline in Basal Insulin Doses | 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. No efficacy data were summarized due to limited enrollment/early termination. | To 52 weeks |
| Change From Baseline in Prandial Insulin Doses | 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. No efficacy data were summarized due to limited enrollment/early termination. | To 52 weeks |
| Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values) | 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. No efficacy data were summarized due to limited enrollment/early termination. | To 52 weeks. |
| Change in Fasting Lipids From Baseline | 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. No efficacy data were summarized due to limited enrollment/early termination. | At weeks 24 and 52 or last observation |
| At weeks 6, 24, and 52 or last observation |
| Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement | 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. No efficacy data were summarized due to limited enrollment/early termination. | At weeks 6, 24, and 52 or last observation |
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
| Pfizer Investigational Site | Vienna | A-1030 | Austria |
| Pfizer Investigational Site | Vienna | A-1130 | Austria |
| Pfizer Investigational Site | Edegem | 2650 | Belgium |
| Pfizer Investigational Site | Genk | 3600 | Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Aarhus | 8000 | Denmark |
| Pfizer Investigational Site | Kuopio | 70211 | Finland |
| Pfizer Investigational Site | Brest | 29609 | France |
| Pfizer Investigational Site | Corbeil-Essonnes | 91106 | France |
| Pfizer Investigational Site | Strasbourg | 67091 | France |
| Pfizer Investigational Site | Waterford | Ireland |
| Pfizer Investigational Site | Amsterdam | NL-1105 AZ | Netherlands |
| Pfizer Investigational Site | Stavanger | 4095 | Norway |
| Pfizer Investigational Site | Lisbon | 1349-019 | Portugal |
| Pfizer Investigational Site | Las Palmas | LAS Palmas de GRAN Canaria | 35016 | Spain |
| Pfizer Investigational Site | Valencia | Valencia | 46010 | Spain |
| Pfizer Investigational Site | Stockholm | 171 76 | Sweden |
| Pfizer Investigational Site | Stockholm | 182 88 | Sweden |
| Pfizer Investigational Site | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| Pfizer Investigational Site | Dundee | Tayside | DD1 9SY | United Kingdom |
| Pfizer Investigational Site | Birmingham | West Midlands | B9 5SS | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Exubera ® | Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine. |
| BG001 | Insulin Lispro | Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Safety population. | Number | participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) | 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. No efficacy data were summarized due to limited enrollment/early termination. | Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Number | percent | At 52 weeks |
|
| ||||||||||||||||||||
| Secondary | Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8% | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Number | percent | At 52 weeks |
|
| ||||||||||||||||||||
| Secondary | Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0% | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Number | percent | At 52 weeks |
|
| ||||||||||||||||||||
| Secondary | Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Number | percent | At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation. |
|
| ||||||||||||||||||||
| Secondary | Change From Baseline in FPG | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dl) | At 52 weeks or last observation |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | mg/dl | To 52 weeks |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | mg/dl | To 52 weeks |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Insulin Antibody Levels | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | ml | At weeks 24 and 52 or last observation. |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Body Weight | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | kg | At weeks 12, 24, 36, and 52 or last observation. |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Body Mass Index | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | kilograms per meter squared (kg/m2) | At weeks 12, 24, 36, and 52 or last observation. |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Basal Insulin Doses | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | International Units (IU) | To 52 weeks |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Prandial Insulin Doses | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | IU | To 52 weeks |
|
| |||||||||||||||||||
| Secondary | Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values) | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Number | mg/dl | To 52 weeks. |
|
| ||||||||||||||||||||
| Other Pre-specified | Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Number | scores on scale | At weeks 6, 24, and 52 or last observation |
|
| ||||||||||||||||||||
| Secondary | Change in Fasting Lipids From Baseline | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Mean | Standard Deviation | mg/dl | At weeks 24 and 52 or last observation |
|
| |||||||||||||||||||
| Other Pre-specified | Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement | 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. No efficacy data were summarized due to limited enrollment/early termination. | ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided. | Posted | Number | scores on scale | At weeks 6, 24, and 52 or last observation |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exubera ® | Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine. | 2 | 35 | ||||
| EG001 | Insulin Lispro | Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine. | 1 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatinine increased | Investigations | MedDRA (v11.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (v11.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aphthous stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Drug intolerance | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Hunger | General disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Balanitis candida | Infections and infestations | Systematic Assessment |
| ||
| Ear infection | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Localised infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Onychomycosis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection viral | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| Tracheitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Vaginal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Viral pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginitis | Infections and infestations | Systematic Assessment |
| ||
| Eye injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Joint sprain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Weight increased | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Polydipsia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Tendonitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Disturbance in attention | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Disorientation | Psychiatric disorders | Systematic Assessment |
| ||
| Mental disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Ketonuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Polyuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngolaryngeal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash macular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hot flush | Vascular disorders | Systematic Assessment |
| ||
| Hypertensive crisis | Vascular disorders | Systematic Assessment |
|
As a result of Pfizer's decision to stop marketing Exubera ®, this study was terminated. Due to the early termination of the study and the low number of subjects who completed, no descriptive statistics for efficacy endpoints are provided.
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 |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C473734 | Exubera |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|