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Trial record 1 of 1 for:    NCT00143247
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Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00143247
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 2, 2005
Results First Posted : November 9, 2009
Last Update Posted : April 15, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Results First Submitted Date  ICMJE January 16, 2009
Results First Posted Date  ICMJE November 9, 2009
Last Update Posted Date April 15, 2010
Study Start Date  ICMJE March 2003
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
  • Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment [ Time Frame: Baseline to 126 months ]
    Change from Baseline: mean of (value of observed forced expiratory volume in 1 second (FEV1) (liters) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
  • Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment [ Time Frame: baseline to 126 months ]
    Change from Baseline: mean of (value of observed Carbon Monoxide Diffusing Capacity (mL/min/mm Hg) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
To observe, in subjects with long-term exposure to inhaled insulin, pulmonary function over time.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2010)
  • Change in Glycosylated Hemoglobin by Duration of Exubera Treatment [ Time Frame: Baseline to 126 months ]
    Change from Baseline: mean of (value of observed glycosylated hemoglobin (HbA1C) (percent) at treatment duration minus baseline value). Duration of treatment is based on the elapsed duration of treatment in the controlled and uncontrolled studies. Baseline was based on pre-inhaled insulin measurements.
  • Hypoglycemic Event Rates by Interval of Exubera Treatment [ Time Frame: 0 to 132 months ]
    Number of hypoglycemic events per subject-month. Subject-month determined by time on treatment. Interval of treatment based on elapsed duration of treatment in the controlled & uncontrolled studies.Overall represents entire duration of treatment. Hypoglycemia: Characteristic symptoms of hypoglycemia with no blood glucose check. Clinical picture must include prompt resolution with food intake, subcutaneous glucagon or intravenous glucose.OR,Characteristic symptoms of hypoglycemia with blood glucose check showing glucose <=59 mg/dl.OR,Any glucose measurement <=49 mg/dl,with or without symptoms.
  • Severe Hypoglycemic Event Rates by Interval of Exubera Treatment [ Time Frame: 0-132 months ]
    Number of severe hypoglycemic events per 100 subject-months.Subject-month determined by time on treatment.Interval of treatment based on elapsed duration of treatment in controlled & uncontrolled studies.Overall represents entire duration of treatment.A severe hypoglycemic event must have met all 3of following:1.subject unable to treat self.2.subject exhibited 1 or more of neurological symptoms defined in protocol.3.blood glucose must be <=49 mg/dl if measured.If not measured,clinical manifestations must have been reversed by oral carbohydrates,subcutaneous glucagon,or intravenous glucose.
  • Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes [ Time Frame: 36 months to 126 months ]
    Observed values by duration of treatment.
  • Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry) [ Time Frame: 36 to 126 months ]
    observed values by duration of treatment.
  • Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry) [ Time Frame: 6 to 120 months ]
    Observed values by duration of treatment.
  • Number of Decliners in Either Forced Expiratory Volume in 1 Second (L) or Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg), by Duration of Exubera Treatment [ Time Frame: 3 to >=108 months ]
    Decliners = decline of ≥15% in forced expiratory volume or ≥20% in carbon monoxide diffusing capacity.
  • Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment [ Time Frame: 3 to >=108 months ]
    Decliners at particular timepoint were defined as any decline of ≥15% in forced expiratory volume.
  • Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment [ Time Frame: 6 to >=108 months ]
    Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • The following parameters will be observed:
  • general safety,
  • insulin antibodies,
  • HbA1c,
  • fasting plasma glucose,
  • hypoglycemic episodes,
  • mean daily insulin doses,
  • body weight, and
  • fasting lipid profile.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus
Official Title  ICMJE An Open-Label, Phase 2, Long-Term Safety Study of Inhaled Insulin: An Up to Four-Year Extension of Therapy in Subjects With Type 1 or Type 2 Diabetes Mellitus Participating in Extension Protocols 217-102, 103, or 104
Brief Summary This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).
Detailed Description The study was terminated on Oct. 18, 2007. This study is not a post approval commitment study. Pfizer decided to cancel new trials because of the decision to withdraw Exubera® (inhaled insulin) due to lack of market performance and not for safety reasons.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Drug: Exubera® (inhaled insulin)
Treatment of type 1 and type 2 diabetes with short-acting insulin
Other Name: Exubera®
Study Arms  ICMJE Experimental: Exubera® (inhaled insulin)
Open label, no comparator
Intervention: Drug: Exubera® (inhaled insulin)
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: November 3, 2009)
173
Original Enrollment  ICMJE
 (submitted: August 31, 2005)
85
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with Type 1 or Type 2 Diabetes Mellitus who participated in previous Phase 2 extension protocols

Exclusion Criteria:

  • Smoking
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143247
Other Study ID Numbers  ICMJE A2171036
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 July 2009

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