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A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00282971
Recruitment Status : Terminated (Terminated as marketing of this product will be discontinued)
First Posted : January 27, 2006
Results First Posted : August 26, 2009
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus Type 2
Interventions Drug: Inhaled Insulin (Exubera)
Other: Standard of Care
Enrollment 354
Recruitment Details  
Pre-assignment Details Total subjects enrolled=354. Total subjects given study drug=351. (ie, 3 subjects withdrew after enrollment/randomization, but prior to receiving study drug)
Arm/Group Title Inhaled Insulin Standard of Care
Hide Arm/Group Description Inhaled insulin plus oral therapy Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Period Title: Overall Study
Started 180 171
Completed 146 149
Not Completed 34 22
Arm/Group Title Inhaled Insulin Standard of Care Total
Hide Arm/Group Description Inhaled insulin plus oral therapy Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators Total of all reporting groups
Overall Number of Baseline Participants 180 171 351
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 180 participants 171 participants 351 participants
<18 years 0 0 0
Between 18 and 44 years 12 6 18
Between 45 and 64 years 112 113 225
>=65 years 56 52 108
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 171 participants 351 participants
Female
76
  42.2%
80
  46.8%
156
  44.4%
Male
104
  57.8%
91
  53.2%
195
  55.6%
1.Primary Outcome
Title Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Hide Description [(week 24 value - baseline value)/baseline value]*100%
Time Frame 4, 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.
Arm/Group Title Inhaled Insulin Standard of Care
Hide Arm/Group Description:
Inhaled insulin plus oral therapy
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Overall Number of Participants Analyzed 179 170
Mean (Standard Deviation)
Unit of Measure: percentage change
week 4 (n=164 and 158, respectively) -1.08  (0.61) -0.62  (0.55)
week 12 (n=159 and 150, respectively) -2.03  (0.97) -1.37  (0.92)
week 24 (n=142 and 150, respectively) -2.02  (1.10) -1.44  (1.10)
week 24 (LOCF, n=175 and 170, respectively) -1.94  (1.09) -1.42  (1.09)
2.Secondary Outcome
Title Percentage of Participants Achieving Glycemic Control by Visit
Hide Description 2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
Time Frame 4, 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively. LOCF=last observation carried forward.
Arm/Group Title Inhaled Insulin Standard of Care
Hide Arm/Group Description:
Inhaled insulin plus oral therapy
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Overall Number of Participants Analyzed 179 170
Measure Type: Number
Unit of Measure: Percentage of participants
HbA1c<=7% at week 4 (n=165 and 158 respectively) 6.1 0.0
HbA1c<=7% at week 12 (n=160 and 150 respectively) 38.1 11.3
HbA1c<=7% at week 24 (n=143 and 150 respectively) 34.3 12.0
HbA1c<=7% at wk-24 LOCF (n=178 & 170 respectively) 32.0 12.9
HbA1c<=6.5% at week 4 (n=165 and 158 respectively) 0.6 0.0
HbA1c<=6.5% at week 12 (n=160 &150 respectively) 15.6 4.7
HbA1c<=6.5% at week 24 (n=143 &150 respectively) 18.2 6.0
HbA1c<=6.5% at wk-24 LOCF(n=178 &170 respectively) 15.2 5.9
3.Secondary Outcome
Title Change From Baseline in FEV1 at Week 24 LOCF
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.FEV1=forced expiratory volume in 1 second;LOCF=last observation carried forward.
Arm/Group Title Inhaled Insulin Standard of Care
Hide Arm/Group Description:
Inhaled insulin plus oral therapy
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Overall Number of Participants Analyzed 179 170
Mean (Standard Deviation)
Unit of Measure: Liter
-0.27  (9.85) -0.08  (0.61)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inhaled Insulin Standard of Care
Hide Arm/Group Description Inhaled insulin plus oral therapy Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
All-Cause Mortality
Inhaled Insulin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Inhaled Insulin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   8/180 (4.44%)   6/171 (3.51%) 
Cardiac disorders     
Acute myocardial infarction  1  1/180 (0.56%)  0/171 (0.00%) 
Cardiac failure  1  1/180 (0.56%)  0/171 (0.00%) 
Coronary artery disease  1  0/180 (0.00%)  1/171 (0.58%) 
Myocardial infarction  1  0/180 (0.00%)  1/171 (0.58%) 
Gastrointestinal disorders     
Pancreatitis acute  1  0/180 (0.00%)  1/171 (0.58%) 
General disorders     
Oedema peripheral  1  1/180 (0.56%)  0/171 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/180 (0.56%)  0/171 (0.00%) 
Infections and infestations     
Incision site cellulitis  1  1/180 (0.56%)  0/171 (0.00%) 
Injury, poisoning and procedural complications     
Device malfunction  1  1/180 (0.56%)  0/171 (0.00%) 
Investigations     
Blood glucose increase  1  1/180 (0.56%)  0/171 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  0/180 (0.00%)  1/171 (0.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  1/180 (0.56%)  1/171 (0.58%) 
Prostate cancer  1  0/180 (0.00%)  1/171 (0.58%) 
Nervous system disorders     
Cerebrovascular accident  1  1/180 (0.56%)  0/171 (0.00%) 
Transient ischaemic attack  1  0/180 (0.00%)  1/171 (0.58%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/180 (0.56%)  0/171 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Inhaled Insulin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   123/180 (68.33%)   98/171 (57.31%) 
Gastrointestinal disorders     
Abdominal pain  1  2/180 (1.11%)  4/171 (2.34%) 
Diarrhoea  1  4/180 (2.22%)  3/171 (1.75%) 
General disorders     
Asthenia  1  5/180 (2.78%)  6/171 (3.51%) 
Fatigue  1  4/180 (2.22%)  3/171 (1.75%) 
Pyrexia  1  4/180 (2.22%)  1/171 (0.58%) 
Infections and infestations     
Bronchitis  1  5/180 (2.78%)  2/171 (1.17%) 
Influenza  1  6/180 (3.33%)  7/171 (4.09%) 
Nasopharyngitis  1  8/180 (4.44%)  4/171 (2.34%) 
Upper respiratory tract infection  1  5/180 (2.78%)  5/171 (2.92%) 
Urinary tract infection  1  7/180 (3.89%)  6/171 (3.51%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  118/180 (65.56%)  98/171 (57.31%) 
Nervous system disorders     
Dizziness  1  6/180 (3.33%)  3/171 (1.75%) 
Headache  1  2/180 (1.11%)  6/171 (3.51%) 
Tremor  1  8/180 (4.44%)  5/171 (2.92%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/180 (5.56%)  2/171 (1.17%) 
Vascular disorders     
Hypertension  1  2/180 (1.11%)  4/171 (2.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
Study terminated prematurely since the sponsor stopped marketing and manufacturing of EXUBERA and withdrew Market Authorization in Europe in September 2008. No efficacy, safety, or quality reason was associated with the premature halt of this study.
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 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info 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
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00282971    
Other Study ID Numbers: A2171063
EXACTA ( Other Identifier: Alias Study Number )
2005-003504-11 ( EudraCT Number )
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: February 11, 2009
Results First Posted: August 26, 2009
Last Update Posted: April 2, 2019