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

August 25, 2009 updated by: Pfizer

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes mellitus Type 1

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire
Time Frame: At weeks 6, 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.
At weeks 6, 24, and 52 or last observation
Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement
Time Frame: At weeks 6, 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.
At weeks 6, 24, and 52 or last observation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

September 2, 2009

Last Update Submitted That Met QC Criteria

August 25, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2171035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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