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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Inhaled Human Insulin (Exubera®)
* Drug: Insulin lispro (Humalog)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes mellitus Type 1 Exclusion Criteria: Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD) Smoking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Drug: Insulin lispro (Humalog)<br>* Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.<br>|
| Experimental: Experimental<br> | Drug: Inhaled Human Insulin (Exubera®)<br>* Preprandial inhaled insulin regimen and administration of insulin glargine QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%) | 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. | At 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8% | 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. | At 52 weeks | 
| Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0% | 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. | At 52 weeks | 
| 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 | 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. | At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation. | 
| Change From Baseline in FPG | 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. | At 52 weeks or last observation | 
| Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments | 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. | To 52 weeks | 
| Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments | 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. | To 52 weeks | 
| Change From Baseline in Insulin Antibody Levels | 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. | At weeks 24 and 52 or last observation. | 
| Change From Baseline in Body Weight | 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. | At weeks 12, 24, 36, and 52 or last observation. | 
| Change From Baseline in Body Mass Index | 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. | At weeks 12, 24, 36, and 52 or last observation. | 
| Change From Baseline in Basal Insulin Doses | 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. | To 52 weeks | 
| Change From Baseline in Prandial Insulin Doses | 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. | To 52 weeks | 
| Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values) | 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. | To 52 weeks. | 
| Change in Fasting Lipids From Baseline | 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. | At weeks 24 and 52 or last observation |