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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00391027

Purpose

To compare efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Inhaled Human Insulin (Exubera) Drug: Insulin Glargine (Lantus)	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline to week 26 in glycosylated hemoglobin (HbA1c) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of patients achieving good glycemic control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Change from baseline in body weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
24-hour glucose excursions in a subset of patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Patient preference and quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	478
Study Start Date:	December 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Insulin Glargine (Lantus): Active Comparator	Drug: Insulin Glargine (Lantus) Patient will be randomized to Lantus while remaining on pre-study oral hypoglycemic agents.
Inhaled Human Insulin (Exubera): Active Comparator	Drug: Inhaled Human Insulin (Exubera) Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391027

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171084
Study First Received:	October 19, 2006
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00391027
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

type 2 diabetes, insulin, glycemic control

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
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 15, 2009