| Trial ID: | L4679 |
| Source ID: | NCT00356421
|
| Associated Drug: |
Inhaled Human Insulin (Exubera®)
|
| Title: |
A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00356421/results
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Inhaled Human Insulin (Exubera®)|DRUG: Insulin lispro (Humalog)
|
| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%), As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At 52 weeks | Secondary: Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At 52 weeks|Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At 52 weeks|Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.|Change From Baseline in FPG, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At 52 weeks or last observation|Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., To 52 weeks|Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., To 52 weeks|Change From Baseline in Insulin Antibody Levels, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At weeks 24 and 52 or last observation.|Change From Baseline in Body Weight, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At weeks 12, 24, 36, and 52 or last observation.|Change From Baseline in Body Mass Index, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At weeks 12, 24, 36, and 52 or last observation.|Change From Baseline in Basal Insulin Doses, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., To 52 weeks|Change From Baseline in Prandial Insulin Doses, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., To 52 weeks|Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values), As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., To 52 weeks.|Change in Fasting Lipids From Baseline, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At weeks 24 and 52 or last observation | Other: Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At weeks 6, 24, and 52 or last observation|Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement, As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination., At weeks 6, 24, and 52 or last observation
|
| Sponsor/Collaborators: |
Sponsor: Pfizer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
58
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-11
|
| Completion Date: |
2008-06
|
| Results First Posted: |
2009-08-11
|
| Last Update Posted: |
2009-09-02
|
| Locations: |
Pfizer Investigational Site, Hamilton, New Jersey, 08610, United States|Pfizer Investigational Site, New Brunswick, New Jersey, 08903, United States|Pfizer Investigational Site, Vienna, A-1030, Austria|Pfizer Investigational Site, Vienna, A-1130, Austria|Pfizer Investigational Site, Edegem, 2650, Belgium|Pfizer Investigational Site, Genk, 3600, Belgium|Pfizer Investigational Site, Leuven, 3000, Belgium|Pfizer Investigational Site, Aarhus, 8000, Denmark|Pfizer Investigational Site, Kuopio, 70211, Finland|Pfizer Investigational Site, Brest CEDEX, 29609, France|Pfizer Investigational Site, Corbeil Essonnes Cedex, 91106, France|Pfizer Investigational Site, Strasbourg Cedex, 67091, France|Pfizer Investigational Site, Waterford, Ireland|Pfizer Investigational Site, Amsterdam, NL-1105 AZ, Netherlands|Pfizer Investigational Site, Stavanger, 4095, Norway|Pfizer Investigational Site, Lisboa, 1349-019, Portugal|Pfizer Investigational Site, Las Palmas, Las Palmas de Gran Canaria, 35016, Spain|Pfizer Investigational Site, Valencia, 46010, Spain|Pfizer Investigational Site, Stockholm, 171 76, Sweden|Pfizer Investigational Site, Stockholm, 182 88, Sweden|Pfizer Investigational Site, Bournemouth, Dorset, BH7 7DW, United Kingdom|Pfizer Investigational Site, Dundee, Tayside, DD1 9SY, United Kingdom|Pfizer Investigational Site, Birmingham, West Midlands, B9 5SS, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00356421
|
