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Trial record 1 of 1 for:    NCT00356421
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A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

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ClinicalTrials.gov Identifier: NCT00356421
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : July 26, 2006
Results First Posted : August 11, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 24, 2006
First Posted Date  ICMJE July 26, 2006
Results First Submitted Date  ICMJE June 24, 2009
Results First Posted Date  ICMJE August 11, 2009
Last Update Posted Date September 2, 2009
Study Start Date  ICMJE November 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) [ Time Frame: At 52 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
Change of glycosylated hemoglobin from baseline to 52 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2009)
  • Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8% [ Time Frame: At 52 weeks ]
    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.
  • Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0% [ Time Frame: At 52 weeks ]
    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.
  • 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 [ Time Frame: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation. ]
    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.
  • Change From Baseline in FPG [ Time Frame: At 52 weeks or last observation ]
    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.
  • Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments [ Time Frame: To 52 weeks ]
    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.
  • Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments [ Time Frame: To 52 weeks ]
    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.
  • Change From Baseline in Insulin Antibody Levels [ Time Frame: At weeks 24 and 52 or last observation. ]
    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.
  • Change From Baseline in Body Weight [ Time Frame: At weeks 12, 24, 36, and 52 or last observation. ]
    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.
  • Change From Baseline in Body Mass Index [ Time Frame: At weeks 12, 24, 36, and 52 or last observation. ]
    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.
  • Change From Baseline in Basal Insulin Doses [ Time Frame: To 52 weeks ]
    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.
  • Change From Baseline in Prandial Insulin Doses [ Time Frame: To 52 weeks ]
    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.
  • Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values) [ Time Frame: To 52 weeks. ]
    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.
  • Change in Fasting Lipids From Baseline [ Time Frame: At weeks 24 and 52 or last observation ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
  • Change in glycosylated hemoglobin from baseline to 52 weeks
  • Incidence of Hypoglycemia from baseline to 52 weeks
  • Change in lipids from baseline to 52 weeks
  • Change in insulin antibody titers from baseline to 52 weeks
  • Change in glucose disposition from basebaseline to 24 weeks
  • Change in diurnal glycemic excursions from baseline to 52 weeks
  • Change in quality of life from baseline 52 weeks
Current Other Pre-specified Outcome Measures
 (submitted: August 25, 2009)
  • Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire [ Time Frame: At weeks 6, 24, and 52 or last observation ]
    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.
  • Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement [ Time Frame: At weeks 6, 24, and 52 or last observation ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
Official Title  ICMJE A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus
Brief Summary To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus
Detailed Description Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera®, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera®. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Inhaled Human Insulin (Exubera®)
    Preprandial inhaled insulin regimen and administration of insulin glargine QD
  • Drug: Insulin lispro (Humalog)
    Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.
Study Arms  ICMJE
  • Active Comparator: Control
    Intervention: Drug: Insulin lispro (Humalog)
  • Experimental: Experimental
    Intervention: Drug: Inhaled Human Insulin (Exubera®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 24, 2009)
58
Original Enrollment  ICMJE
 (submitted: July 24, 2006)
340
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes mellitus Type 1

Exclusion Criteria:

  • Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
  • Smoking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Finland,   France,   Ireland,   Netherlands,   Norway,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT00356421
Other Study ID Numbers  ICMJE A2171035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP