A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

Phase 4

Terminated

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin lispro (Humalog); Drug: Inhaled Human Insulin (Exubera®)

• Registration Number: NCT00356421
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-26
• Study Start: 2006-11
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2009-01
• Results First Submitted: 2009-06-24
• Results First Submitted QC: 2009-06-24
• Results First Posted: 2009-08-11
• Last Update Submitted: 2009-08-25
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Diabetes mellitus Type 1

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Exclusion Criteria

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
• Smoking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Insulin lispro (Humalog)	-
Experimental	Inhaled Human Insulin (Exubera®)	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)	At 52 weeks	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments	To 52 weeks	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Change From Baseline in Insulin Antibody Levels	At weeks 24 and 52 or last observation.	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Change From Baseline in Body Weight	At weeks 12, 24, 36, and 52 or last observation.	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Change From Baseline in Body Mass Index	At weeks 12, 24, 36, and 52 or last observation.	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Change From Baseline in Basal Insulin Doses	To 52 weeks	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Change From Baseline in Prandial Insulin Doses	To 52 weeks	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)	To 52 weeks.	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Change in Fasting Lipids From Baseline	At weeks 24 and 52 or last observation	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%	At 52 weeks	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%	At 52 weeks	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
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	At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Change From Baseline in FPG	At 52 weeks or last observation	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments	To 52 weeks	As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Birmingham, West Midlands, United Kingdom