A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00437489

Purpose

The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Inhaled Human Insulin (Exubera)	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, Efficacy Study
Official Title:	A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control 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 in glycosylated hemoglobin (HbA1c) [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of Exubera [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in fasting plasma glucose [ Time Frame: At week 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
Incidence of overall and severe hypoglycemia [ Time Frame: Collected at baseline (week 0) and at week 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: Yes ]
Time from initial to stable prescribed dose for Exubera [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change from baseline in mean average blood glucose based on 7-point blood glucose profile [ Time Frame: Collected at week 1, 4, 8 and at 16 ] [ Designated as safety issue: No ]
Proportion of subjects achieving HbA1c < 7.0% or < 6.5% [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
Incidence of nocturnal hypoglycemia collected at baseline (week 0) and [ Time Frame: At week 1, 2, 4, 8, 12 and 16 ] [ Designated as safety issue: Yes ]

Enrollment:	49
Study Start Date:	April 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: Active Comparator	Drug: Inhaled Human Insulin (Exubera) Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
Experimental: Experimental	Drug: Inhaled Human Insulin (Exubera) Initial dose of 1mg TID of inhaled human insulin

Eligibility

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

Criteria

Inclusion Criteria:

Diabetes mellitus Type 2
Currently treated with at least 2 oral anti-diabetic agents

Exclusion Criteria:

Severe Asthma, severe COPD
Smoking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437489

Locations

Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong
Pakistan, Sindh
Pfizer Investigational Site
Karachi, Sindh, Pakistan, 74600
Philippines
Pfizer Investigational Site
Quezon City, Philippines, 1102
Pfizer Investigational Site
Marikina City, Philippines, 1810
Pfizer Investigational Site
Pasay City, Philippines, 1300
Pfizer Investigational Site
Pasig City, Philippines, 1605
Pfizer Investigational Site
Makati, Philippines, 1218
Singapore
Pfizer Investigational Site
Singapore, Singapore, 119074
Pfizer Investigational Site
Singapore, Singapore, 159964

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

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171086
Study First Received:	February 20, 2007
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00437489
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
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