Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00359801

Purpose

The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An International, Multicenter, Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus

Further study details as provided by Pfizer:

Primary Outcome Measures:

Persistent decline in FEV1 exceeding 20% from baseline, defined as an observed decline in FEV1 exceeding 20% from baseline, 3 months after a confirmed decline in FEV1 exceeding 20% from baseline. [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Allergic response SAE composite, including: SAEs of anaphylaxis, angioedema, generalized allergic reaction, or allergic bronchospasm [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Change in HbA1c from baseline [ Time Frame: 32 months ] [ Designated as safety issue: No ]
Pulmonary serious adverse event (SAE) composite, including: SAEs of asthma, chronic obstructive pulmonary disease (COPD), pneumonia, or acute bronchitis [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
All-cause mortality [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]
Cardiovascular SAE composite, including: SAEs of cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: 32 months ] [ Designated as safety issue: Yes ]

Enrollment:	1985
Study Start Date:	July 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Exubera: Experimental	Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.
Usual Diabetes Care: Active Comparator	Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Arms

Assigned Interventions

Exubera: Experimental

Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions.

Usual Diabetes Care: Active Comparator

Drug: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care

Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Eligible for receiving Exubera treatment based on the approved local label

Exclusion Criteria:

Pregnant or lactating
Have a progressive fatal disease or a life expectancy that prohibits them from participating in a five-year research study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359801

Show 200 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171069
Study First Received:	July 31, 2006
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00359801
Health Authority:	European Union: European Medicines Agency

Keywords provided by Pfizer:

Large Simple Trial

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009