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Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety (VOLUME)

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ClinicalTrials.gov Identifier: NCT00359801
Recruitment Status : Completed
First Posted : August 2, 2006
Results First Posted : January 27, 2010
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus
Intervention Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Enrollment 1976
Recruitment Details Subjects were recruited from primary care centers, diabetes and endocrinology clinics, and academic centers, and participated in the study between 22 July 2006 and 29 April 2009.
Pre-assignment Details  
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description Exubera® plus usual diabetes care Usual diabetes care
Period Title: Overall Study
Started 987 989
Completed 682 [1] 769 [2]
Not Completed 305 220
Reason Not Completed
Lost to Follow-up             72             58
Withdrawal by Subject             143             96
Other             66             46
Final Status Unknown: missing data             7             4
Sponsor Decision             17             16
[1]
7 additional subjects had missing data and final status (completed/discontinued) is unknown.
[2]
4 additional subjects had missing data and final status (completed/discontinued) is unknown.
Arm/Group Title Exubera® Non-Exubera® Total
Hide Arm/Group Description Exubera® plus usual diabetes care Usual diabetes care Total of all reporting groups
Overall Number of Baseline Participants 987 989 1976
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 987 participants 989 participants 1976 participants
18-44 years 114 133 247
45-64 years 576 552 1128
65-74 years 242 245 487
75-84 years 52 57 109
>= 85 years 3 2 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 987 participants 989 participants 1976 participants
Female
439
  44.5%
434
  43.9%
873
  44.2%
Male
548
  55.5%
555
  56.1%
1103
  55.8%
1.Primary Outcome
Title Number of Subjects With Decline in Forced Expiratory Volume (FEV1) Exceeding 20% From Baseline
Hide Description Persistent decline in FEV1 exceeding 20% from baseline: observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline (2 consecutive declines within 1 month) in FEV1 exceeding 20% from baseline. Second pulmonary function test (PFT) that confirmed decline was to occur within 14-42 days of the decline. Persistence: PFT that established persistence was to occur within 60-120 days of the confirming (2nd) decline. Index Visit: date subject had final Scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.
Time Frame Baseline, Month 6, Year 1, Year 2, Index Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all randomized subjects.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 987 989
Measure Type: Number
Unit of Measure: participants
Initial FEV1 Decline 100 112
Initial FEV1 Decline but not a Confirmed Decline 81 105
Confirmed FEV1 Decline 19 7
Confirmed FEV1 Decline but not Persistent Decline 11 7
Persistent FEV1 Decline 8 0
2.Primary Outcome
Title Supplemental Definition of Decline in Forced Expiratory Volume in One Second (FEV1): Number of Subjects
Hide Description Confirmed FEV1 decline: any two consecutive declines that are >= 14 days apart. The pulmonary function test that established persistence occured >= 60 days after the initial decline. A confirmed decline: any two consecutive declines ≥ 14 days apart. The third PFT that established persistence was to occur ≥ 60 days after the initial decline. Index Visit: date the subject had his/her final scheduled spirometry was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.
Time Frame Baseline, Month 6, Year 1, Year 2, Index Visit
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 987 989
Measure Type: Number
Unit of Measure: participants
Initial FEV1 Decline 100 112
Initial FEV1 Decline but not a Confirmed Decline 62 74
Confirmed FEV1 Decline 38 38
Confirmed FEV1 Decline but not Persistent Decline 11 14
Persistent FEV1 Decline 27 24
3.Primary Outcome
Title Time to Persistent Decline in FEV1 Exceeding 20% From Baseline
Hide Description Elapsed time, in days, from the start of subject's participation in the study to the first reading of FEV1 that is: 20% or more below the subject's latest pre-study measurement, subsequently confirmed as a >20% decline [(baseline observed value minus visit observed value)/by baseline observed value *100], and assessed as persistent as defined by protocol process. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to latest valid FEV1 measurement for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Hide Description Change from Baseline: mean of value of observed forced expiratory volume in the first second of forced exhalation [FEV1] in liters [L] at observation minus Baseline value. Index Visit: date subject had final scheduled spirometry; was to occur within 2 months of Institutional Review Board/Ethics approval of April 2008 amendment.
Time Frame Baseline, Week 26, Week 52, Week 104, Index Visit
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 987 989
Mean (Standard Deviation)
Unit of Measure: liters
Baseline (n=985, 987) 2.661  (0.838) 2.684  (0.888)
Week 26 (n=813, 852) -0.009  (0.568) -0.035  (0.509)
Week 52 (n=470, 482) -0.032  (0.411) -0.056  (0.465)
Week 104 (n=3, 1) -0.103  (0.607) -1.270  (0.000)
Index Visit (n=729, 803) -0.000  (0.559) -0.018  (0.580)
5.Secondary Outcome
Title Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis
Hide Description Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite: definite pneumonia, definite COPD, or definite asthma; possible: possible pneumonia, possible COPD, possible asthma, probable obstructive lung disease not otherwise specified or probable acute bronchitis; definite or possible: either definite or possible; insufficient: insufficient data.
Time Frame Baseline through End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 987 989
Measure Type: Number
Unit of Measure: events
Definite 4 1
Possible 3 2
Definite or Possible 7 3
Insufficient 4 2
6.Secondary Outcome
Title Time to Event for Pulmonary Serious Adverse Event (SAE) Composite: SAEs of Asthma, Chronic Obstructive Pulmonary Disease (COPD), Pneumonia, or Acute Bronchitis
Hide Description Elapsed time, in days, from the start of a subject's participation in the study to the date of the first report of an event subsequently confirmed (according to protocol definition) as meeting the criteria for pulmonary SAE composite. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title All-cause Mortality: Number of Deaths
Hide Description Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria (confirmation of deaths by blinded adjudicator(s) through medical records or death certificates). Patients meeting the endpoint All Cause Mortality after adjudication by the endpoint committee.
Time Frame Baseline through End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 987 989
Measure Type: Number
Unit of Measure: participants
12 9
8.Secondary Outcome
Title Time to Event: All-cause Mortality
Hide Description Time to all-cause mortality: elapsed time, in days, from the start of a subject's participation in the study to the date of the event subsequently confirmed (according to protocol definition) as meeting the criteria for all-cause mortality. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Cardiovascular SAE Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
Hide Description Endpoint committee adjudicated based on review of medical/hospital records; results classified using standard criteria. Definite: definite MI or stroke; Possible: possible MI or stroke; Other (non-MI, non-stroke): other cardiovascular event (non-MI, non-stroke); Definite or possible: either definite or possible or both; Insufficient: insufficient data; Death from cardiovascular or cerebrovascular: cardiovascular or cerebrovascular event; Definite or possible or death from cardiovascular or cerebrovascular: either definite or possible or both or cardiovascular or cerebrovascular event.
Time Frame Baseline through End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 987 989
Measure Type: Number
Unit of Measure: events
Definite 5 3
Possible 5 6
Other (non-myocardial infarction, non-stroke) 15 9
Definite or Possible 10 9
Insufficient 9 7
Death from Cardiovascular or Cerebrovascular 2 4
Definite or Possible, or Death from Cardiovascular 12 11
10.Secondary Outcome
Title Time to Event for Cardiovascular Serious Adverse Event (SAE) Composite: SAEs of Cardiovascular Mortality, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Hide Description Elapsed time, in days, from the start of a subject's participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for cardiovascular SAE composite. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Allergic Response Serious Adverse Event (SAE) Composite: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm
Hide Description Endpoint committee adjudicated the endpoint based on review of medical and hospital records, and results were classified using standard criteria. Definite or possible: anaphylaxis, angioedema/urticaria, bronchospasm or possible allergic reaction not otherwise specified (NOS); Insufficient: insufficient data.
Time Frame Baseline through End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 987 989
Measure Type: Number
Unit of Measure: events
Definite or Possible 2 0
Insufficient 3 0
12.Secondary Outcome
Title Time to Event for Allergic Response Serious Adverse Event (SAE) Composite, Including: SAEs of Anaphylaxis, Angioedema, Generalized Allergic Reaction, or Allergic Bronchospasm
Hide Description Elapsed time, in days, from the start of a subject's participation in the study to the date of the first event subsequently confirmed (according to protocol definition) as meeting the criteria for allergic response. Censoring time: elapsed time, in days, from the start of a subject's participation in the study to the latest contact with the subject for the particular analysis set of interest. Cox proportional hazards model to estimate treatment effect.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Due to early study termination, originally planned inferential analysis for time to event was not done.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change in Glycosylated Hemoglobin (HbA1c) From Baseline
Hide Description Baseline HbA1c: the latest determination prior to beginning study participation. Change from Baseline: HbA1c at observation (falling within the time window associated with a given analysis set) minus the baseline value.
Time Frame Baseline, Month 6, Year 1, Year 2, Index Visit
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; (n) = number of subjects with analyzable data at observation for Exubera® and Non-Exubera®, respectively.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 987 989
Mean (Standard Deviation)
Unit of Measure: percent
Baseline (n=978, 985) 8.6  (1.9) 8.5  (1.9)
Week 26: Observed Value (804, 849) 8.0  (1.8) 8.0  (1.8)
Week 26: Change from Baseline (n=800, 848) -0.5  (1.7) -0.5  (1.6)
Week 52: Observed Value (n=468, 489) 7.8  (1.7) 7.7  (1.6)
Week 52: Change from Baseline (n=467, 489) -0.4  (1.6) -0.6  (1.6)
Week 104: Observed Value (n=3, 1) 6.6  (1.2) 6.0  (0)
Week 104: Change from Baseline (n=3, 1) -1.0  (1.6) -2.7  (0)
Index Visit: Observed Value (n=673, 754) 8.1  (3.0) 8.0  (3.5)
Index Visit: Change from Baseline (n=669, 754) -0.3  (2.9) -0.5  (3.3)
14.Secondary Outcome
Title Change in Glycosylated Hemoglobin (HbA1c) From Baseline
Hide Description Baseline HbA1c taken as the latest determination prior to beginning study participation. Change = on-study value (for measurements falling within the time window associated with a given analysis set) minus the baseline value. Linear model with terms for treatment, baseline HbA1c, time on study, and subject within treatment.
Time Frame Baseline to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Due to early study termination, the originally planned inferential analysis (linear model) for change from baseline was not done.
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description:
Exubera® plus usual diabetes care
Usual diabetes care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Two additional subjects experienced SAEs that were not listed under a treatment group due to data error: Injury, Poisoning and Procedural Complications system organ class (1 subject; drug exposure during preganancy), and Musculoskeletal and Connective System Disorders System Organ Class (1 subject; neuropathic arthropathy).
 
Arm/Group Title Exubera® Non-Exubera®
Hide Arm/Group Description Exubera® plus usual diabetes care Usual diabetes care
All-Cause Mortality
Exubera® Non-Exubera®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Exubera® Non-Exubera®
Affected / at Risk (%) Affected / at Risk (%)
Total   124/987 (12.56%)   109/989 (11.02%) 
Blood and lymphatic system disorders     
Anaemia † 1  2/987 (0.20%)  0/989 (0.00%) 
Iron deficiency anaemia † 1  1/987 (0.10%)  1/989 (0.10%) 
Lymphatic obstruction † 1  0/987 (0.00%)  1/989 (0.10%) 
Cardiac disorders     
Acute coronary syndrome † 1  1/987 (0.10%)  0/989 (0.00%) 
Angina pectoris † 1  2/987 (0.20%)  3/989 (0.30%) 
Angina unstable † 1  0/987 (0.00%)  2/989 (0.20%) 
Aortic valve incompetence † 1  1/987 (0.10%)  0/989 (0.00%) 
Arrhythmia † 1  2/987 (0.20%)  1/989 (0.10%) 
Arteriosclerosis coronary artery † 1  1/987 (0.10%)  0/989 (0.00%) 
Atrial fibrillation † 1  2/987 (0.20%)  1/989 (0.10%) 
Atrial flutter † 1  1/987 (0.10%)  0/989 (0.00%) 
Atrial tachycardia † 1  1/987 (0.10%)  0/989 (0.00%) 
Cardiac arrest † 1  0/987 (0.00%)  1/989 (0.10%) 
Cardiac failure † 1  0/987 (0.00%)  1/989 (0.10%) 
Cardiac failure congestive † 1  3/987 (0.30%)  1/989 (0.10%) 
Cardio-respiratory arrest † 1  1/987 (0.10%)  0/989 (0.00%) 
Cardiomyopathy † 1  0/987 (0.00%)  1/989 (0.10%) 
Congestive cardiomyopathy † 1  1/987 (0.10%)  0/989 (0.00%) 
Coronary artery disease † 1  5/987 (0.51%)  2/989 (0.20%) 
Coronary artery occlusion † 1  0/987 (0.00%)  2/989 (0.20%) 
Coronary artery stenosis † 1  2/987 (0.20%)  1/989 (0.10%) 
Hypertensive heart disease † 1  1/987 (0.10%)  0/989 (0.00%) 
Ischaemic cardiomyopathy † 1  1/987 (0.10%)  0/989 (0.00%) 
Myocardial infarction † 1  5/987 (0.51%)  4/989 (0.40%) 
Myocardial ischaemia † 1  1/987 (0.10%)  0/989 (0.00%) 
Paroxysmal arrhythmia † 1  1/987 (0.10%)  0/989 (0.00%) 
Tricuspid valve incompetence † 1  1/987 (0.10%)  0/989 (0.00%) 
Ventricular tachycardia † 1  1/987 (0.10%)  1/989 (0.10%) 
Congenital, familial and genetic disorders     
Cerebral palsy † 1  1/987 (0.10%)  0/989 (0.00%) 
Endocrine disorders     
Goitre † 1  1/987 (0.10%)  0/989 (0.00%) 
Eye disorders     
Blindness † 1  0/987 (0.00%)  1/989 (0.10%) 
Cataract † 1  1/987 (0.10%)  1/989 (0.10%) 
Diabetic retinopathy † 1  1/987 (0.10%)  0/989 (0.00%) 
Eye degenerative disorder † 1  0/987 (0.00%)  1/989 (0.10%) 
Macular oedema † 1  0/987 (0.00%)  1/989 (0.10%) 
Gastrointestinal disorders     
Abdominal hernia † 1  0/987 (0.00%)  1/989 (0.10%) 
Abdominal pain † 1  0/987 (0.00%)  1/989 (0.10%) 
Colitis ulcerative † 1  0/987 (0.00%)  1/989 (0.10%) 
Duodenitis † 1  1/987 (0.10%)  0/989 (0.00%) 
Gastric haemorrhage † 1  1/987 (0.10%)  0/989 (0.00%) 
Gastritis † 1  0/987 (0.00%)  2/989 (0.20%) 
Gastrointestinal haemorrhage † 1  2/987 (0.20%)  1/989 (0.10%) 
Inguinal hernia † 1  2/987 (0.20%)  1/989 (0.10%) 
Pancreatitis † 1  0/987 (0.00%)  1/989 (0.10%) 
Pancreatitis acute † 1  0/987 (0.00%)  1/989 (0.10%) 
Pancreatitis chronic † 1  1/987 (0.10%)  0/989 (0.00%) 
Small intestinal obstruction † 1  1/987 (0.10%)  0/989 (0.00%) 
Volvulus † 1  0/987 (0.00%)  1/989 (0.10%) 
General disorders     
Cardiac death † 1  0/987 (0.00%)  1/989 (0.10%) 
Chest discomfort † 1  1/987 (0.10%)  1/989 (0.10%) 
Chest pain † 1  7/987 (0.71%)  9/989 (0.91%) 
Death † 1  2/987 (0.20%)  1/989 (0.10%) 
Discomfort † 1  1/987 (0.10%)  0/989 (0.00%) 
Drug ineffective † 1  2/987 (0.20%)  0/989 (0.00%) 
Inflammation † 1  1/987 (0.10%)  0/989 (0.00%) 
Malaise † 1  1/987 (0.10%)  0/989 (0.00%) 
Oedema peripheral † 1  1/987 (0.10%)  0/989 (0.00%) 
Organ failure † 1  0/987 (0.00%)  1/989 (0.10%) 
Sudden death † 1  1/987 (0.10%)  1/989 (0.10%) 
Hepatobiliary disorders     
Biliary colic † 1  1/987 (0.10%)  0/989 (0.00%) 
Cholecystitis acute † 1  0/987 (0.00%)  1/989 (0.10%) 
Cholelithiasis † 1  0/987 (0.00%)  2/989 (0.20%) 
Immune system disorders     
Drug hypersensitivity † 1  1/987 (0.10%)  0/989 (0.00%) 
Infections and infestations     
Abscess † 1  0/987 (0.00%)  1/989 (0.10%) 
Abscess neck † 1  1/987 (0.10%)  0/989 (0.00%) 
Appendicitis † 1  0/987 (0.00%)  1/989 (0.10%) 
Cellulitis † 1  2/987 (0.20%)  2/989 (0.20%) 
Diverticulitis † 1  1/987 (0.10%)  0/989 (0.00%) 
Empyema † 1  0/987 (0.00%)  1/989 (0.10%) 
Erysipelas † 1  1/987 (0.10%)  0/989 (0.00%) 
Gangrene † 1  0/987 (0.00%)  1/989 (0.10%) 
Gastroenteritis † 1  0/987 (0.00%)  1/989 (0.10%) 
Gastrointestinal infection † 1  1/987 (0.10%)  0/989 (0.00%) 
Herpes zoster † 1  0/987 (0.00%)  1/989 (0.10%) 
Infected skin ulcer † 1  0/987 (0.00%)  1/989 (0.10%) 
Lobar pneumonia † 1  1/987 (0.10%)  0/989 (0.00%) 
Lower respiratory tract infection † 1  0/987 (0.00%)  1/989 (0.10%) 
Lymph node tuberculosis † 1  1/987 (0.10%)  0/989 (0.00%) 
Pneumonia † 1  3/987 (0.30%)  2/989 (0.20%) 
Pyelonephritis † 1  0/987 (0.00%)  1/989 (0.10%) 
Scrotal abscess † 1  1/987 (0.10%)  0/989 (0.00%) 
Sepsis † 1  1/987 (0.10%)  1/989 (0.10%) 
Staphylococcal infection † 1  1/987 (0.10%)  0/989 (0.00%) 
Subcutaneous abscess † 1  1/987 (0.10%)  1/989 (0.10%) 
Tooth abscess † 1  0/987 (0.00%)  1/989 (0.10%) 
Urinary tract infection † 1  0/987 (0.00%)  1/989 (0.10%) 
Injury, poisoning and procedural complications     
Accident † 1  0/987 (0.00%)  1/989 (0.10%) 
Acetabulum fracture † 1  1/987 (0.10%)  0/989 (0.00%) 
Ankle fracture † 1  2/987 (0.20%)  2/989 (0.20%) 
Compression fracture † 1  0/987 (0.00%)  1/989 (0.10%) 
Device malfunction † 1  1/987 (0.10%)  0/989 (0.00%) 
Device occlusion † 1  1/987 (0.10%)  0/989 (0.00%) 
Drug exposure during pregnancy † 1  1/987 (0.10%)  0/989 (0.00%) 
Fall † 1  3/987 (0.30%)  2/989 (0.20%) 
Head injury † 1  1/987 (0.10%)  1/989 (0.10%) 
Hip fracture † 1  0/987 (0.00%)  1/989 (0.10%) 
Implantable defibrillator malfunction † 1  0/987 (0.00%)  1/989 (0.10%) 
Lower limb fracture † 1  0/987 (0.00%)  1/989 (0.10%) 
Meniscus lesion † 1  1/987 (0.10%)  0/989 (0.00%) 
Multiple injuries † 1  1/987 (0.10%)  0/989 (0.00%) 
Paternal drugs affecting foetus † 1  0/987 (0.00%)  1/989 (0.10%) 
Post procedural haematoma † 1  1/987 (0.10%)  0/989 (0.00%) 
Rib fracture † 1  1/987 (0.10%)  1/989 (0.10%) 
Scapula fracture † 1  0/987 (0.00%)  1/989 (0.10%) 
Subdural haematoma † 1  1/987 (0.10%)  2/989 (0.20%) 
Tendon rupture † 1  2/987 (0.20%)  0/989 (0.00%) 
Therapeutic agent toxicity † 1  1/987 (0.10%)  0/989 (0.00%) 
Wound † 1  1/987 (0.10%)  0/989 (0.00%) 
Investigations     
Anti-insulin antibody increased † 1  1/987 (0.10%)  0/989 (0.00%) 
Blood glucose decreased † 1  1/987 (0.10%)  0/989 (0.00%) 
Blood glucose increased † 1  3/987 (0.30%)  0/989 (0.00%) 
Catheterisation cardiac † 1  0/987 (0.00%)  1/989 (0.10%) 
Forced expiratory volume decreased † 1  1/987 (0.10%)  0/989 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1  0/987 (0.00%)  1/989 (0.10%) 
Diabetes mellitus † 1  1/987 (0.10%)  0/989 (0.00%) 
Diabetes mellitus inadequate control † 1  2/987 (0.20%)  1/989 (0.10%) 
Diabetic complication † 1  0/987 (0.00%)  1/989 (0.10%) 
Diabetic foot † 1  1/987 (0.10%)  0/989 (0.00%) 
Diabetic ketoacidosis † 1  1/987 (0.10%)  5/989 (0.51%) 
Hypercalcaemia † 1  0/987 (0.00%)  1/989 (0.10%) 
Hyperglycaemia † 1  2/987 (0.20%)  2/989 (0.20%) 
Hyperkalaemia † 1  0/987 (0.00%)  1/989 (0.10%) 
Hypoglycaemia † 1  7/987 (0.71%)  6/989 (0.61%) 
Ketoacidosis † 1  1/987 (0.10%)  0/989 (0.00%) 
Obesity † 1  1/987 (0.10%)  0/989 (0.00%) 
Type 1 diabetes mellitus † 1  0/987 (0.00%)  1/989 (0.10%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  1/987 (0.10%)  0/989 (0.00%) 
Arthropathy † 1  0/987 (0.00%)  1/989 (0.10%) 
Back pain † 1  1/987 (0.10%)  0/989 (0.00%) 
Intervertebral disc disorder † 1  0/987 (0.00%)  1/989 (0.10%) 
Intervertebral disc protrusion † 1  4/987 (0.41%)  0/989 (0.00%) 
Monarthritis † 1  1/987 (0.10%)  0/989 (0.00%) 
Neuropathic arthropathy † 1  2/987 (0.20%)  0/989 (0.00%) 
Osteoarthritis † 1  2/987 (0.20%)  2/989 (0.20%) 
Osteonecrosis † 1  1/987 (0.10%)  0/989 (0.00%) 
Rotator cuff syndrome † 1  0/987 (0.00%)  2/989 (0.20%) 
Spinal column stenosis † 1  1/987 (0.10%)  0/989 (0.00%) 
Spinal disorder † 1  1/987 (0.10%)  0/989 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia † 1  1/987 (0.10%)  0/989 (0.00%) 
Adenocarcinoma pancreas † 1  0/987 (0.00%)  1/989 (0.10%) 
B-cell lymphoma † 1  1/987 (0.10%)  0/989 (0.00%) 
Basal cell carcinoma † 1  0/987 (0.00%)  1/989 (0.10%) 
Breast cancer † 1  1/987 (0.10%)  0/989 (0.00%) 
Colon cancer † 1  1/987 (0.10%)  0/989 (0.00%) 
Gammopathy † 1  1/987 (0.10%)  0/989 (0.00%) 
Glioblastoma † 1  1/987 (0.10%)  0/989 (0.00%) 
Hepatic neoplasm malignant † 1  1/987 (0.10%)  1/989 (0.10%) 
Leukaemia † 1  0/987 (0.00%)  1/989 (0.10%) 
Lipoma † 1  0/987 (0.00%)  1/989 (0.10%) 
Lung neoplasm malignant † 1  3/987 (0.30%)  0/989 (0.00%) 
Lymphoma † 1  1/987 (0.10%)  0/989 (0.00%) 
Metastases to liver † 1  1/987 (0.10%)  0/989 (0.00%) 
Metastatic neoplasm † 1  1/987 (0.10%)  0/989 (0.00%) 
Non-Hodgkin's lymphoma † 1  1/987 (0.10%)  0/989 (0.00%) 
Pancreatic carcinoma † 1  1/987 (0.10%)  1/989 (0.10%) 
Prostate cancer † 1  0/987 (0.00%)  1/989 (0.10%) 
Renal cell carcinoma † 1  0/987 (0.00%)  1/989 (0.10%) 
Renal neoplasm † 1  0/987 (0.00%)  1/989 (0.10%) 
Squamous cell carcinoma † 1  1/987 (0.10%)  1/989 (0.10%) 
Uterine leiomyoma † 1  0/987 (0.00%)  2/989 (0.20%) 
Nervous system disorders     
Brain stem infarction † 1  1/987 (0.10%)  0/989 (0.00%) 
Carotid artery stenosis † 1  1/987 (0.10%)  1/989 (0.10%) 
Central nervous system lesion † 1  1/987 (0.10%)  0/989 (0.00%) 
Cerebral infarction † 1  1/987 (0.10%)  0/989 (0.00%) 
Cerebrovascular accident † 1  6/987 (0.61%)  3/989 (0.30%) 
Convulsion † 1  0/987 (0.00%)  4/989 (0.40%) 
Facial paresis † 1  1/987 (0.10%)  0/989 (0.00%) 
Haemorrhage intracranial † 1  0/987 (0.00%)  1/989 (0.10%) 
Paraesthesia † 1  2/987 (0.20%)  0/989 (0.00%) 
Presyncope † 1  0/987 (0.00%)  1/989 (0.10%) 
Sciatica † 1  0/987 (0.00%)  1/989 (0.10%) 
Syncope † 1  2/987 (0.20%)  4/989 (0.40%) 
Thalamic infarction † 1  0/987 (0.00%)  1/989 (0.10%) 
Transient ischaemic attack † 1  2/987 (0.20%)  1/989 (0.10%) 
Psychiatric disorders     
Depression † 1  1/987 (0.10%)  0/989 (0.00%) 
Drug abuse † 1  1/987 (0.10%)  0/989 (0.00%) 
Emotional disorder † 1  0/987 (0.00%)  1/989 (0.10%) 
Intentional self-injury † 1  1/987 (0.10%)  0/989 (0.00%) 
Mental status changes † 1  1/987 (0.10%)  0/989 (0.00%) 
Suicide attempt † 1  1/987 (0.10%)  0/989 (0.00%) 
Renal and urinary disorders     
Calculus ureteric † 1  1/987 (0.10%)  0/989 (0.00%) 
Hydroureter † 1  0/987 (0.00%)  1/989 (0.10%) 
Nephrolithiasis † 1  1/987 (0.10%)  1/989 (0.10%) 
Renal failure † 1  1/987 (0.10%)  2/989 (0.20%) 
Renal failure chronic † 1  2/987 (0.20%)  0/989 (0.00%) 
Tubulointerstitial nephritis † 1  1/987 (0.10%)  0/989 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  0/987 (0.00%)  1/989 (0.10%) 
Chronic obstructive pulmonary disease † 1  1/987 (0.10%)  0/989 (0.00%) 
Dyspnoea † 1  5/987 (0.51%)  1/989 (0.10%) 
Dyspnoea exertional † 1  1/987 (0.10%)  0/989 (0.00%) 
Lung disorder † 1  0/987 (0.00%)  1/989 (0.10%) 
Lung infiltration † 1  1/987 (0.10%)  0/989 (0.00%) 
Pulmonary embolism † 1  0/987 (0.00%)  2/989 (0.20%) 
Pulmonary mass † 1  1/987 (0.10%)  0/989 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema † 1  1/987 (0.10%)  0/989 (0.00%) 
Blister † 1  0/987 (0.00%)  1/989 (0.10%) 
Decubitus ulcer † 1  0/987 (0.00%)  1/989 (0.10%) 
Dermal cyst † 1  1/987 (0.10%)  0/989 (0.00%) 
Diabetic ulcer † 1  1/987 (0.10%)  0/989 (0.00%) 
Pruritus † 1  1/987 (0.10%)  0/989 (0.00%) 
Surgical and medical procedures     
Cardiac operation † 1  1/987 (0.10%)  0/989 (0.00%) 
Coronary arterial stent insertion † 1  0/987 (0.00%)  1/989 (0.10%) 
Coronary artery bypass † 1  0/987 (0.00%)  1/989 (0.10%) 
Toe amputation † 1  1/987 (0.10%)  0/989 (0.00%) 
Vascular disorders     
Accelerated hypertension † 1  0/987 (0.00%)  1/989 (0.10%) 
Aortic stenosis † 1  1/987 (0.10%)  0/989 (0.00%) 
Arterial occlusive disease † 1  1/987 (0.10%)  1/989 (0.10%) 
Deep vein thrombosis † 1  0/987 (0.00%)  1/989 (0.10%) 
Haematoma † 1  1/987 (0.10%)  0/989 (0.00%) 
Hypertension † 1  1/987 (0.10%)  0/989 (0.00%) 
Hypertensive crisis † 1  0/987 (0.00%)  1/989 (0.10%) 
Hypotension † 1  0/987 (0.00%)  1/989 (0.10%) 
Orthostatic hypotension † 1  0/987 (0.00%)  1/989 (0.10%) 
Peripheral arterial occlusive disease † 1  1/987 (0.10%)  0/989 (0.00%) 
Peripheral artery aneurysm † 1  0/987 (0.00%)  1/989 (0.10%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exubera® Non-Exubera®
Affected / at Risk (%) Affected / at Risk (%)
Total   26/987 (2.63%)   11/989 (1.11%) 
Cardiac disorders     
Angina pectoris † 1  1/987 (0.10%)  0/989 (0.00%) 
Eye disorders     
Vision blurred † 1  1/987 (0.10%)  0/989 (0.00%) 
Gastrointestinal disorders     
Gingival pain † 1  1/987 (0.10%)  0/989 (0.00%) 
Nausea † 1  0/987 (0.00%)  1/989 (0.10%) 
General disorders     
Adverse drug reaction † 1  1/987 (0.10%)  0/989 (0.00%) 
Fatigue † 1  1/987 (0.10%)  1/989 (0.10%) 
Influenza like illness † 1  1/987 (0.10%)  0/989 (0.00%) 
Oedema peripheral † 1  1/987 (0.10%)  0/989 (0.00%) 
Infections and infestations     
Bronchitis † 1  1/987 (0.10%)  0/989 (0.00%) 
Cellulitis † 1  0/987 (0.00%)  1/989 (0.10%) 
Gingival infection † 1  1/987 (0.10%)  0/989 (0.00%) 
Herpes zoster † 1  1/987 (0.10%)  0/989 (0.00%) 
Lobar pneumonia † 1  1/987 (0.10%)  0/989 (0.00%) 
Nasopharyngitis † 1  0/987 (0.00%)  1/989 (0.10%) 
Sinusitis † 1  1/987 (0.10%)  0/989 (0.00%) 
Skin bacterial infection † 1  1/987 (0.10%)  0/989 (0.00%) 
Staphylococcal infection † 1  1/987 (0.10%)  0/989 (0.00%) 
Upper respiratory tract infection † 1  1/987 (0.10%)  0/989 (0.00%) 
Viral pharyngitis † 1  1/987 (0.10%)  0/989 (0.00%) 
Injury, poisoning and procedural complications     
Tooth fracture † 1  1/987 (0.10%)  0/989 (0.00%) 
Investigations     
Blood glucose increased † 1  3/987 (0.30%)  0/989 (0.00%) 
Cardiac murmur † 1  1/987 (0.10%)  0/989 (0.00%) 
Catheterisation cardiac † 1  0/987 (0.00%)  1/989 (0.10%) 
Forced expiratory volume decreased † 1  0/987 (0.00%)  2/989 (0.20%) 
Weight decreased † 1  1/987 (0.10%)  0/989 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia † 1  1/987 (0.10%)  1/989 (0.10%) 
Hypoglycaemia † 1  2/987 (0.20%)  1/989 (0.10%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity † 1  1/987 (0.10%)  0/989 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm † 1  0/987 (0.00%)  1/989 (0.10%) 
Nervous system disorders     
Facial palsy † 1  1/987 (0.10%)  0/989 (0.00%) 
Haemorrhage intracranial † 1  0/987 (0.00%)  1/989 (0.10%) 
Headache † 1  1/987 (0.10%)  0/989 (0.00%) 
Psychiatric disorders     
Insomnia † 1  1/987 (0.10%)  0/989 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1  0/987 (0.00%)  1/989 (0.10%) 
Cough † 1  6/987 (0.61%)  0/989 (0.00%) 
Dry throat † 1  1/987 (0.10%)  0/989 (0.00%) 
Dyspnoea † 1  3/987 (0.30%)  0/989 (0.00%) 
Oropharyngeal pain † 1  1/987 (0.10%)  0/989 (0.00%) 
Painful respiration † 1  1/987 (0.10%)  0/989 (0.00%) 
Pulmonary congestion † 1  1/987 (0.10%)  0/989 (0.00%) 
Wheezing † 1  1/987 (0.10%)  0/989 (0.00%) 
Skin and subcutaneous tissue disorders     
Stasis dermatitis † 1  0/987 (0.00%)  1/989 (0.10%) 
Surgical and medical procedures     
Stent placement † 1  1/987 (0.10%)  0/989 (0.00%) 
Vascular disorders     
Temporal arteritis † 1  1/987 (0.10%)  0/989 (0.00%) 
Vascular stenosis † 1  1/987 (0.10%)  0/989 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Pursuant to Pfizer's announcement that it would exit marketing of Exubera®, study enrollment was halted on 26-October-2007.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00359801    
Other Study ID Numbers: A2171069
First Submitted: July 31, 2006
First Posted: August 2, 2006
Results First Submitted: December 22, 2009
Results First Posted: January 27, 2010
Last Update Posted: February 2, 2010