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

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin Insulin beef Insulin lispro Insulin glargine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) [ Time Frame: At 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8% [ Time Frame: At 52 weeks ] [ Designated as safety issue: No ]
Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0% [ Time Frame: At 52 weeks ] [ Designated as safety issue: No ]
Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline [ Time Frame: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation. ] [ Designated as safety issue: No ]
Change From Baseline in FPG [ Time Frame: At 52 weeks or last observation ] [ Designated as safety issue: No ]
Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Insulin Antibody Levels [ Time Frame: At weeks 24 and 52 or last observation. ] [ Designated as safety issue: No ]
Change From Baseline in Body Weight [ Time Frame: At weeks 12, 24, 36, and 52 or last observation. ] [ Designated as safety issue: No ]
Change From Baseline in Body Mass Index [ Time Frame: At weeks 12, 24, 36, and 52 or last observation. ] [ Designated as safety issue: No ]
Change From Baseline in Basal Insulin Doses [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Prandial Insulin Doses [ Time Frame: To 52 weeks ] [ Designated as safety issue: No ]
Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values) [ Time Frame: To 52 weeks. ] [ Designated as safety issue: No ]
Change in Fasting Lipids From Baseline [ Time Frame: At weeks 24 and 52 or last observation ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	November 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control	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 Chronic Obstructive Pulmonary Disease (COPD)
Smoking

Contacts and Locations

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

Locations

United States, New Jersey
Pfizer Investigational Site
Hamilton, New Jersey, United States, 08610
Pfizer Investigational Site
New Brunswick, New Jersey, United States, 08903
Austria
Pfizer Investigational Site
Vienna, Austria, A-1130
Pfizer Investigational Site
Vienna, Austria, A-1030
Belgium
Pfizer Investigational Site
Edegem, Belgium, 2650
Pfizer Investigational Site
Genk, Belgium, 3600
Pfizer Investigational Site
Leuven, Belgium, 3000
Denmark
Pfizer Investigational Site
Aarhus, Denmark, 8000
Finland
Pfizer Investigational Site
Kuopio, Finland, 70211
France
Pfizer Investigational Site
Brest CEDEX, France, 29609
Pfizer Investigational Site
Corbeil Essonnes Cedex, France, 91106
Pfizer Investigational Site
Strasbourg Cedex, France, 67091
Ireland
Pfizer Investigational Site
Waterford, Ireland
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, NL-1105 AZ
Norway
Pfizer Investigational Site
Stavanger, Norway, 4095
Portugal
Pfizer Investigational Site
Lisboa, Portugal, 1349-019
Spain
Pfizer Investigational Site
Las Palmas, Las Palmas de Gran Canaria, Spain, 35016
Pfizer Investigational Site
Valencia, Spain, 46010
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 182 88
Pfizer Investigational Site
Stockholm, Sweden, 171 76
United Kingdom
Pfizer Investigational Site
Bournemouth, Dorset, United Kingdom, BH7 7DW
Pfizer Investigational Site
Dundee, Tayside, United Kingdom, DD1 9SY
Pfizer Investigational Site
Birmingham, West Midlands, United Kingdom, B9 5SS

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00356421 History of Changes
Other Study ID Numbers:	A2171035
Study First Received:	July 24, 2006
Results First Received:	June 24, 2009
Last Updated:	August 25, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

Insulin LISPRO
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012