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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00143247
• Other study ID #: A2171036
• Status: Terminated
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: April 10, 2010
• Start date: March 2003
• Est. completion date: January 2008

Study information

• Verified date: July 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 173
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Smoking

• Pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Exubera® (inhaled insulin)
Treatment of type 1 and type 2 diabetes with short-acting insulin

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Forced Expiratory Volume in 1 Second (L) by Time on Exubera Treatment	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.	Baseline to 126 months	Yes
Primary	Change in Carbon Monoxide Diffusing Capacity (mL/Min/mm Hg) by Time on Exubera Treatment	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.	baseline to 126 months	Yes
Secondary	Change in Glycosylated Hemoglobin by Duration of Exubera Treatment	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.	Baseline to 126 months	No
Secondary	Hypoglycemic Event Rates by Interval of Exubera Treatment	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.	0 to 132 months	No
Secondary	Severe Hypoglycemic Event Rates by Interval of Exubera Treatment	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.	0-132 months	No
Secondary	Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 1 Diabetes	Observed values by duration of treatment.	36 months to 126 months	Yes
Secondary	Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Using Insulin at Study Entry)	observed values by duration of treatment.	36 to 126 months	Yes
Secondary	Insulin Antibodies (Percent Binding) by Time on Exubera Treatment - Subjects With Type 2 Diabetes (Not Using Insulin at Study Entry)	Observed values by duration of treatment.	6 to 120 months	Yes
Secondary	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	Decliners = decline of =15% in forced expiratory volume or =20% in carbon monoxide diffusing capacity.	3 to >=108 months	Yes
Secondary	Number of Decliners in Forced Expiratory Volume in 1 Second (L) by Duration of Exubera Treatment	Decliners at particular timepoint were defined as any decline of =15% in forced expiratory volume.	3 to >=108 months	Yes
Secondary	Number of Decliners in Carbon Monoxide Diffusing Capacity (ml/Min/mm Hg) by Duration of Exubera Treatment	Decliners at particular timepoint were defined as any decline of =20% in carbon monoxide diffusing capacity.	6 to >=108 months	Yes

External Links

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