A Clinical Trial Comparing Efficacy and Safety of Exubera and Humalog - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00356421

Purpose

To compare efficacy and safety of Exubera vs Humalog in patients with type 1 diabetes mellitus

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Inhaled Human Insulin (Exubera) Drug: Insulin lispro (Humalog)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin lispro Insulin glargine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change of glycosylated hemoglobin from baseline [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in glycosylated hemoglobin from baseline [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
Incidence of Hypoglycemia from baseline [ Time Frame: To 52 weeks ] [ Designated as safety issue: Yes ]
Change in lipids from baseline [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
Change in insulin antibody titers from baseline [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
Change in glucose disposition from baseline [ Time Frame: To 24 weeks ] [ Designated as safety issue: No ]
Change in diurnal glycemic excursions from baseline [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
Change in quality of life from baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	340
Study Start Date:	November 2006
Study Completion Date:	June 2008

Arms	Assigned Interventions
Control: Active Comparator	Drug: Insulin lispro (Humalog) Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.
Experimental: Experimental	Drug: Inhaled Human Insulin (Exubera) Preprandial inhaled insulin regimen and administration of insulin glargine QD

Detailed Description:

Pfizer announced in October 2007 that it would stop marketing Exubera. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.

Eligibility

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

Criteria

Inclusion Criteria:

Diabetes mellitus Type 1

Exclusion Criteria:

Severe Asthma, severe COPD
Smoking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356421

Show 23 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171035
Study First Received:	July 24, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00356421 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Diabetes Mellitus Type 1
Insulin

Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO

Insulin
Pharmacologic Actions
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 02, 2009