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

NCT ID: NCT00356421

Last Updated: 2009-09-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-06-30

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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Insulin lispro (Humalog)

Intervention Type DRUG

Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.

Experimental

Group Type EXPERIMENTAL

Inhaled Human Insulin (Exubera®)

Intervention Type DRUG

Preprandial inhaled insulin regimen and administration of insulin glargine QD

Interventions

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Inhaled Human Insulin (Exubera®)

Preprandial inhaled insulin regimen and administration of insulin glargine QD

Intervention Type DRUG

Insulin lispro (Humalog)

Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetes mellitus Type 1

Exclusion Criteria

* Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
* Smoking
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Hamilton, New Jersey, United States

Site Status

Pfizer Investigational Site

New Brunswick, New Jersey, United States

Site Status

Pfizer Investigational Site

Vienna, , Austria

Site Status

Pfizer Investigational Site

Vienna, , Austria

Site Status

Pfizer Investigational Site

Edegem, , Belgium

Site Status

Pfizer Investigational Site

Genk, , Belgium

Site Status

Pfizer Investigational Site

Leuven, , Belgium

Site Status

Pfizer Investigational Site

Aarhus, , Denmark

Site Status

Pfizer Investigational Site

Kuopio, , Finland

Site Status

Pfizer Investigational Site

Brest, , France

Site Status

Pfizer Investigational Site

Corbeil-Essonnes, , France

Site Status

Pfizer Investigational Site

Strasbourg, , France

Site Status

Pfizer Investigational Site

Waterford, , Ireland

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Pfizer Investigational Site

Stavanger, , Norway

Site Status

Pfizer Investigational Site

Lisbon, , Portugal

Site Status

Pfizer Investigational Site

Las Palmas, LAS Palmas de GRAN Canaria, Spain

Site Status

Pfizer Investigational Site

Valencia, Valencia, Spain

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Bournemouth, Dorset, United Kingdom

Site Status

Pfizer Investigational Site

Dundee, Tayside, United Kingdom

Site Status

Pfizer Investigational Site

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United States Austria Belgium Denmark Finland France Ireland Netherlands Norway Portugal Spain Sweden United Kingdom

Related Links

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Other Identifiers

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A2171035

Identifier Type: -

Identifier Source: org_study_id

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