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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Inhaled Human Insulin (Exubera®)
Insulin lispro (Humalog)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 24, 2006
Last Updated
August 25, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00356421
Brief Title
A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Inhaled Human Insulin (Exubera®)
Intervention Description
Preprandial inhaled insulin regimen and administration of insulin glargine QD
Intervention Type
Drug
Intervention Name(s)
Insulin lispro (Humalog)
Intervention Description
Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)
Description
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.
Time Frame
At 52 weeks
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%
Description
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.
Time Frame
At 52 weeks
Title
Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%
Description
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.
Time Frame
At 52 weeks
Title
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
Description
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.
Time Frame
At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.
Title
Change From Baseline in FPG
Description
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.
Time Frame
At 52 weeks or last observation
Title
Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments
Description
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.
Time Frame
To 52 weeks
Title
Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments
Description
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.
Time Frame
To 52 weeks
Title
Change From Baseline in Insulin Antibody Levels
Description
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.
Time Frame
At weeks 24 and 52 or last observation.
Title
Change From Baseline in Body Weight
Description
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.
Time Frame
At weeks 12, 24, 36, and 52 or last observation.
Title
Change From Baseline in Body Mass Index
Description
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.
Time Frame
At weeks 12, 24, 36, and 52 or last observation.
Title
Change From Baseline in Basal Insulin Doses
Description
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.
Time Frame
To 52 weeks
Title
Change From Baseline in Prandial Insulin Doses
Description
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.
Time Frame
To 52 weeks
Title
Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)
Description
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.
Time Frame
To 52 weeks.
Title
Change in Fasting Lipids From Baseline
Description
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.
Time Frame
At weeks 24 and 52 or last observation
Other Pre-specified Outcome Measures:
Title
Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire
Description
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.
Time Frame
At weeks 6, 24, and 52 or last observation
Title
Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement
Description
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.
Time Frame
At weeks 6, 24, and 52 or last observation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes mellitus Type 1 Exclusion Criteria: Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD) Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08610
Country
United States
Facility Name
Pfizer Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Pfizer Investigational Site
City
Vienna
ZIP/Postal Code
A-1030
Country
Austria
Facility Name
Pfizer Investigational Site
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
Pfizer Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Pfizer Investigational Site
City
Brest CEDEX
ZIP/Postal Code
29609
Country
France
Facility Name
Pfizer Investigational Site
City
Corbeil Essonnes Cedex
ZIP/Postal Code
91106
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Pfizer Investigational Site
City
Waterford
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Amsterdam
ZIP/Postal Code
NL-1105 AZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Stavanger
ZIP/Postal Code
4095
Country
Norway
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Las Palmas
State/Province
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171035&StudyName=A%20Clinical%20Trial%20Comparing%20Efficacy%20and%20Safety%20of%20Exubera%20and%20Humalog
Description
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Learn more about this trial

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

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