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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143247
First received: August 31, 2005
Last updated: April 10, 2010
Last verified: July 2009
  Purpose

This is a long-term safety study for Phase 2 subjects who choose to remain on Exubera® (inhaled insulin).


Condition Intervention Phase
Diabetes Mellitus
Drug: Exubera® (inhaled insulin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment [ Time Frame: Baseline to 126 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change in Glycosylated Hemoglobin by Duration of Exubera Treatment [ Time Frame: Baseline to 126 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Decliners at particular timepoint were defined as any decline of ≥20% in carbon monoxide diffusing capacity.


Enrollment: 173
Study Start Date: March 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exubera® (inhaled insulin)
Open label, no comparator
Drug: Exubera® (inhaled insulin)
Treatment of type 1 and type 2 diabetes with short-acting insulin
Other Name: Exubera®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoking
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143247

Locations
United States, California
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06504
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33136
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87131-5666
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
Pfizer Investigational Site
Winston Salem, North Carolina, United States, 27157
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78752
Pfizer Investigational Site
Austin, Texas, United States, 78758
Pfizer Investigational Site
Dallas, Texas, United States, 75243
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00143247     History of Changes
Other Study ID Numbers: A2171036
Study First Received: August 31, 2005
Results First Received: January 16, 2009
Last Updated: April 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014