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See termination reason in detailed description.
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This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.
This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.
Pfizer announced in October 2007 that it would stop marketing Exubera. 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 A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Insulin | Experimental | Inhalable short-acting insulin |
|
| Subcutaneous insulin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Insulin | Drug | Inhaled insulin with dose adjusted according to premeal blood glucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1) | Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value). | Month 3 through extension Month 60 |
| Change From Baseline in FEV1 | Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value). | Baseline through extension follow up Month 3 |
| Annual Rate of Change in FEV1 | Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr). | Week -2 through extension follow up Month 3 or end of study |
| Summary of ≥ 15 % Decliners in FEV1 | Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed. | Month 3 through extension follow up Month 3 |
| Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) | Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr). | Week -2 through extension follow up Month 3 or end of study |
| Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) | Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value). |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity (FVC) | Forced Vital Capacity (FVC) measured in liters (L). | Week -3 through extension follow up Month 3 or end of study |
| Total Lung Capacity (TLC) | Total Lung Capacity measured in liters (L). |
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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 | Phoenix | Arizona | 85016 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19905885 | Derived | Rosenstock J, Cefalu WT, Hollander PA, Klioze SS, Reis J, Duggan WT. Safety and efficacy of inhaled human insulin (exubera) during discontinuation and readministration of therapy in adults with type 2 diabetes: a 3-year randomized controlled trial. Diabetes Technol Ther. 2009 Nov;11(11):697-705. doi: 10.1089/dia.2009.0062. | |
| 18535196 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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At screening visit and during the 4-week run-in phase subjects received subcutaneous insulin regime of 2 to 3 daily doses (QD) of regular insulin-/short-acting insulin analog (lispro or aspart) and 1 or 2 doses QD of intermediate or long-acting insulin (neutral protamine hagedorn [NPH] insulin or Ultralente®) or insulin glargine QD at bedtime.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Insulin (Exubera®) | Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime. |
| FG001 | Subcutaneous Insulin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Subcutaneous insulin | Drug | Subcutaneous insulin with dose adjusted according to premeal blood glucose |
|
| Baseline through extension follow up Month 3 |
| Summary of ≥ 20 % Decliners in DLco | Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed. | Month 3 through extension follow up Month 3 |
| Baseline through extension follow up Month 3 |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value). | Baseline through extension follow up Month 3 |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value). | Baseline through extension follow up Month 3 |
| Change From Baseline in Body Weight | Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value). | Baseline through extension follow up Month 3 |
| Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight) | Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine. | Month 3 through extension Month 36 |
| Total Daily Long-acting Insulin (Adjusted for Body Weight) | Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine. | Month 3 through extension Month 36 |
| Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight) | Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin. | Month 3 through extension Month 36 |
| Total Daily Short-acting Insulin Dose (Adjusted for Body Weight) | Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg). | Month 3 through extension Month 36 |
| Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides | Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL). | Week -4 through Month 24 |
| Hypoglycemic Event Rates | Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval). | Month 1 through extension Month 36 |
| Severe Hypoglycemic Event Rates | Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval. | Month 1 through extension Month 36 |
| Cough Questionnaire | Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection. | Week 0 and if indicated through extension follow up Month 3 |
| Baseline Dyspnea Index (BDI) | Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment. | Week -1 |
| Transition Dyspnea Index (TDI) | Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement. | Week 4 through extension follow up Month 3 or end of study |
| High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits | Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline. | Baseline, M12, M24, Ext M6, Ext M18, Ext M36 |
| High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits | Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. "No" response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn). | Baseline, M12, M24, Ext M6, Ext M18, Ext M36 |
| Insulin Antibodies | Observed values for insulin antibodies measured as micro units per milliliter (microU/mL). | Baseline through extension Month 36 |
| Tucson |
| Arizona |
| 85715 |
| United States |
| Pfizer Investigational Site | Fresno | California | 93720 | United States |
| Pfizer Investigational Site | Greenbrae | California | 94904 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90073 | United States |
| Pfizer Investigational Site | Sacramento | California | 95816 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | San Diego | California | 92108 | United States |
| Pfizer Investigational Site | San Luis Obispo | California | 93401 | United States |
| Pfizer Investigational Site | Tustin | California | 92780 | United States |
| Pfizer Investigational Site | Walnut Creek | California | 94598 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80209 | United States |
| Pfizer Investigational Site | Hamden | Connecticut | 06518 | United States |
| Pfizer Investigational Site | Madison | Connecticut | 06443 | United States |
| Pfizer Investigational Site | New Britain | Connecticut | 06050 | United States |
| Pfizer Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Pfizer Investigational Site | Chiefland | Florida | 32626 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33761 | United States |
| Pfizer Investigational Site | Fort Myers | Florida | 33901 | United States |
| Pfizer Investigational Site | Hollywood | Florida | 33021 | United States |
| Pfizer Investigational Site | Miami | Florida | 33156 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34471 | United States |
| Pfizer Investigational Site | Palm Harbor | Florida | 34684 | United States |
| Pfizer Investigational Site | Tallahassee | Florida | 32308 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33401 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96813 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96814 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60602 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60607 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60610 | United States |
| Pfizer Investigational Site | Springfield | Illinois | 62704 | United States |
| Pfizer Investigational Site | Wilmette | Illinois | 60091 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70112 | United States |
| Pfizer Investigational Site | Bethesda | Maryland | 20817 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48106 | United States |
| Pfizer Investigational Site | Bloomfield Hills | Michigan | 48302 | United States |
| Pfizer Investigational Site | Plymouth | Michigan | 48170 | United States |
| Pfizer Investigational Site | Royal Oak | Michigan | 48073 | United States |
| Pfizer Investigational Site | Southfield | Michigan | 48034 | United States |
| Pfizer Investigational Site | Chesterfield | Missouri | 63017 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63141 | United States |
| Pfizer Investigational Site | Butte | Montana | 59701 | United States |
| Pfizer Investigational Site | Lincoln | Nebraska | 68521 | United States |
| Pfizer Investigational Site | Henderson | Nevada | 89014 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pfizer Investigational Site | Mineola | New York | 11501 | United States |
| Pfizer Investigational Site | New Hyde Park | New York | 11042 | United States |
| Pfizer Investigational Site | Rochester | New York | 14609 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27713 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Mansfield | Ohio | 44903 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Pfizer Investigational Site | Warwick | Rhode Island | 02886 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77701 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77706 | United States |
| Pfizer Investigational Site | Corpus Christi | Texas | 78411 | United States |
| Pfizer Investigational Site | Corpus Christi | Texas | 78412 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Houston | Texas | 77079 | United States |
| Pfizer Investigational Site | Irving | Texas | 75061 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Burlington | Vermont | 05401 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23225 | United States |
| Pfizer Investigational Site | Renton | Washington | 98055 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53209 | United States |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90035-170 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 01244-030 | Brazil |
| Pfizer Investigational Site | Calgary | Alberta | T2T 5C7 | Canada |
| Pfizer Investigational Site | Calgary | Alberta | T3B 0M3 | Canada |
| Pfizer Investigational Site | Red Deer | Alberta | T4N 6V7 | Canada |
| Pfizer Investigational Site | Victoria | British Columbia | V8R 1J8 | Canada |
| Pfizer Investigational Site | Winnepeg | Manitoba | R3A 1R9 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Pfizer Investigational Site | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Pfizer Investigational Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4V2 | Canada |
| Pfizer Investigational Site | Ottawa | Ontario | K1H 1A2 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M4N-3M5 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5G 1X5 | Canada |
| Pfizer Investigational Site | Laval | Quebec | H7T 2P5 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H1T 2M4 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H3A 1A1 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Pfizer Investigational Site | Aguas Buenas | 00703 | Puerto Rico |
| Pfizer Investigational Site | Anasco | 00610 | Puerto Rico |
| Pfizer Investigational Site | Cabo Rojo | 00623 | Puerto Rico |
| Pfizer Investigational Site | San Juan | 00909 | Puerto Rico |
| Pfizer Investigational Site | San Juan | 00921 | Puerto Rico |
| Rosenstock J, Cefalu WT, Hollander PA, Belanger A, Eliaschewitz FG, Gross JL, Klioze SS, St Aubin LB, Foyt H, Ogawa M, Duggan WT. Two-year pulmonary safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 2 diabetes. Diabetes Care. 2008 Sep;31(9):1723-8. doi: 10.2337/dc08-0159. Epub 2008 Jun 5. |
Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime. |
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Insulin (Exubera®) | Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime. |
| BG001 | Subcutaneous Insulin | Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime. |
| 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 | Number | participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| 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 Month 3 in Forced Expiratory Volume in 1 Second (FEV1) | Change from Month 3: mean of (value of observed FEV1 [forced expiratory volume in the first second of forced exhalation] in liters [L] at treatment observation minus Month 3 value). | Full analysis set (FAS) FEV1: received at least 1 dose treatment, had baseline and at least 1 post-baseline FEV1. Due to study termination, originally planned inferential analysis for change from Month 3 through extension Month 60 was not done. Cross reference outcome measure: change from baseline in FEV1. | Posted | Mean | Standard Deviation | L | Month 3 through extension Month 60 |
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| Primary | Change From Baseline in FEV1 | Change from baseline: mean of (value of observed FEV1 [L] at treatment observation minus baseline value). | FAS FEV1; extension Month 36 (M36) Last Observation Carried Forward (LOCF) based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure: change from Month 3 in forced expiratory volume in 1 second. | Posted | Mean | Standard Deviation | L | Baseline through extension follow up Month 3 |
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| Primary | Annual Rate of Change in FEV1 | Annual rate of change in FEV1 calculated as slope over time [visit] for forced expiratory volume in 1 second measured as liters per year (L/yr). | FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in FEV1 were not summarized as planned. | Posted | Mean | Standard Deviation | L/yr | Week -2 through extension follow up Month 3 or end of study |
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| Primary | Summary of ≥ 15 % Decliners in FEV1 | Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed. | FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Number | participants | Month 3 through extension follow up Month 3 |
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| Primary | Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) | Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr). | FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of Annual rate of change in DLco were not summarized as planned. Cross reference outcome measure: change from baseline in Carbon Monoxide Diffusion Capacity (DLco). | Posted | Mean | Standard Deviation | ml/min/mmHg/yr | Week -2 through extension follow up Month 3 or end of study |
|
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| Secondary | Forced Vital Capacity (FVC) | Forced Vital Capacity (FVC) measured in liters (L). | FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of FVC were not summarized as planned. | Posted | Mean | Standard Deviation | L | Week -3 through extension follow up Month 3 or end of study |
|
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| Secondary | Total Lung Capacity (TLC) | Total Lung Capacity measured in liters (L). | FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TLC were not summarized as planned. | Posted | Mean | Standard Deviation | L | Baseline through extension follow up Month 3 |
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| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Change from baseline: mean of (value of observed HbA1c [%] at treatment observation minus baseline value). | FAS HbA1c: received at least 1 dose of study treatment, had baseline HbA1c and at least 1 post-baseline HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Mean | Standard Deviation | percent | Baseline through extension follow up Month 3 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline: mean of (value of observed FPG [milligrams per deciliter (mg/dL)] at treatment observation minus baseline value). | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Mean | Standard Deviation | mg/dL | Baseline through extension follow up Month 3 |
|
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| Secondary | Change From Baseline in Body Weight | Change from baseline: mean of (value of observed body weight [kilograms (kg)] at treatment observation minus baseline value). | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Mean | Standard Deviation | kg | Baseline through extension follow up Month 3 |
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| Secondary | Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight) | Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine. | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Mean | Standard Deviation | units | Month 3 through extension Month 36 |
|
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| Secondary | Total Daily Long-acting Insulin (Adjusted for Body Weight) | Total daily dose of long-acting insulin adjusted for body weight (units per kilogram [kg]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine. | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Mean | Standard Deviation | units/kg | Month 3 through extension Month 36 |
|
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| Secondary | Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight) | Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams [mg]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin. | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Mean | Standard Deviation | mg, units | Month 3 through extension Month 36 |
|
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| Secondary | Total Daily Short-acting Insulin Dose (Adjusted for Body Weight) | Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg). | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Mean | Standard Deviation | mg/kg, units/kg | Month 3 through extension Month 36 |
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| Secondary | Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides | Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL). | FAS: received at least 1 dose of study treatment. Due to early termination of study a limited set of analyses were undertaken and results of Lipids were not summarized as planned. | Posted | Mean | Standard Deviation | mg/dL | Week -4 through Month 24 |
|
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| Primary | Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) | Change from baseline: mean of (value of observed DLco [milliliters per minute per millimeters of mercury (ml/min/mmHg)] at treatment observation minus baseline value). | FAS FEV1; extension M36 LOCF based on data in the extension phase only; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. Cross reference outcome measure Annual rate of change in Carbon Monoxide Diffusion Capacity (DLco). | Posted | Mean | Standard Deviation | ml/min/mmHg | Baseline through extension follow up Month 3 |
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| Primary | Summary of ≥ 20 % Decliners in DLco | Number of subjects with a post-baseline DLco decrease of ≥ 20 % [(baseline observed value - visit observed value)/(baseline observed value) * 100]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed. | FAS FEV1; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Number | participants | Month 3 through extension follow up Month 3 |
|
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| Secondary | Hypoglycemic Event Rates | Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval). | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Number | event rate (events/subject months) | Month 1 through extension Month 36 |
| |||||||||||||||||||||
| Secondary | Severe Hypoglycemic Event Rates | Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 ([total events/subject months]*100). Subjects months: elapsed number of months subject was in study in each time interval. | FAS HbA1c; (n) = number of subjects with analyzable data at observation for inhaled insulin and SC insulin, respectively. | Posted | Number | event rate (events/subject months*100) | Month 1 through extension Month 36 |
| |||||||||||||||||||||
| Secondary | Cough Questionnaire | Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection. | FAS. Due to early termination of study a limited set of analyses were undertaken and results of Cough Questionnaire were not summarized as planned. | Posted | Number | scores on scale | Week 0 and if indicated through extension follow up Month 3 |
| |||||||||||||||||||||
| Secondary | Baseline Dyspnea Index (BDI) | Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment. | FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of BDI were not summarized as planned. | Posted | Number | scores on scale | Week -1 |
|
| ||||||||||||||||||||
| Secondary | Transition Dyspnea Index (TDI) | Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement. | FAS FEV1. Due to early termination of study a limited set of analyses were undertaken and results of TDI were not summarized as planned. | Posted | Number | scores on scale | Week 4 through extension follow up Month 3 or end of study |
| |||||||||||||||||||||
| Secondary | High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits | Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline. | All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete. | Posted | Number | participants | Baseline, M12, M24, Ext M6, Ext M18, Ext M36 |
| |||||||||||||||||||||
| Secondary | High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits | Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. "No" response at observation further categorized as no significant change (NSC), more abnormal (> Abn), or less abnormal (< Abn). | All subjects analysis substudy population: subjects from participating sites with a baseline and subsequent post-baseline HRCT measurement. Subjects were recruited prior to randomization; substudy enrollment continued until at least 50 subjects randomized to inhaled insulin were enrolled or until enrollment in the study was complete. | Posted | Number | participants | Baseline, M12, M24, Ext M6, Ext M18, Ext M36 |
| |||||||||||||||||||||
| Secondary | Insulin Antibodies | Observed values for insulin antibodies measured as micro units per milliliter (microU/mL). | FAS; (n)=number of subjects with analyzable data at observation: inhaled insulin/SC insulin, respectively. Insulin antibody levels increased in Exubera®-treated compared to control subjects; results are included to establish there were no safety consequences due to these elevations although this was not an originally specified protocol endpoint. | Posted | Median | Full Range | microU/mL | Baseline through extension Month 36 |
|
|
Not provided
Adverse events for this study are reported using MedDRA in Basic Results but are reported using COSTART in the Clinical Study Report (CSR) and PhRMA Web Synopsis (PWS) for consistency with earlier studies. Consequently, subtle differences may be observed.
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 | Inhaled Insulin (Exubera®) | Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime. | 76 | 316 | 308 | 316 | ||
| EG001 | Subcutaneous Insulin | Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime. | 76 | 311 | 301 | 311 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Acute myocardial infarctionAcute myocardial infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Coronary artery insufficiency | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gastric volvulus | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Reflux gastritis | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Incision site infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Device migration | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Failure of implant | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Incisional hernia, obstructive | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA (11.1) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
| |
| Cataplexy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Facial palsy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Global amnesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Bipolar II disorder | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Foot amputation | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
| |
| Hysterectomy | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
| |
| Shoulder operation | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
| |
| Vascular operation | Surgical and medical procedures | MedDRA (11.1) | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
Due to early termination of study, none of the subjects completed the study as planned. Subjects active at the time of study termination completed an end-of-study assessment and a 3-month follow-up visit.
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 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information 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 |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C473734 | Exubera |
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Not provided
Not provided
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| Between 46 and 55 years |
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| Between 56 and 65 years |
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| Between 66 and 75 years |
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| Male |
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