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:	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 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
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 Chronic Obstructive Pulmonary Disease (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
Results First Received:	June 24, 2009
Last Updated:	August 25, 2009
ClinicalTrials.gov Identifier:	NCT00356421 History of Changes
Health Authority:	United States: Food and Drug Administration

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 November 27, 2009