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

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Inhaled Human Insulin (Exubera®)

Insulin lispro (Humalog)

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

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

NCT ID

NCT00356421

First Posted

July 24, 2006

Last Updated

August 25, 2009

Sponsor

Pfizer

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

To obtain contact information for a study center near you, click here.

Diabetes Mellitus, Type 1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial