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

• ClinicalTrials.gov Identifier: NCT00143247
• Recruitment Status: Terminated
• First Posted: September 2, 2005
• Results First Posted: November 9, 2009
• Last Update Posted: April 15, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: August 31, 2005
• First Posted Date: September 2, 2005
• Results First Submitted Date: January 16, 2009
• Results First Posted Date: November 9, 2009
• Last Update Posted Date: April 15, 2010
• Study Start Date: March 2003
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: August 31, 2005): To observe, in subjects with long-term exposure to inhaled insulin, pulmonary function over time.

Current Secondary Outcome Measures (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 (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: 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: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus

Intervention

Drug: Exubera® (inhaled insulin)

Treatment of type 1 and type 2 diabetes with short-acting insulin

Other Name: Exubera®

Study Arms

Experimental: Exubera® (inhaled insulin)

Open label, no comparator

Intervention: Drug: Exubera® (inhaled insulin)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 3, 2009): 173
• Original Enrollment (submitted: August 31, 2005): 85
• Actual Study Completion Date: January 2008
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00143247
• Other Study ID Numbers: A2171036
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: July 2009