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

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NCT00356421

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Study Location
Pfizer Investigational Site
Hamilton, New Jersey, 08610, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diabetes mellitus Type 1

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)


- Smoking

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Inhaled Human Insulin (Exubera®)
    Preprandial inhaled insulin regimen and administration of insulin glargine QD
  • Drug: Insulin lispro (Humalog)
    Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.
Study Arms  ICMJE
  • Active Comparator: Control
    Intervention: Drug: Insulin lispro (Humalog)
  • Experimental: Experimental
    Intervention: Drug: Inhaled Human Insulin (Exubera®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 24, 2009)		58
Original Enrollment  ICMJE
 (submitted: July 24, 2006)		340
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diabetes mellitus Type 1

Exclusion Criteria:

  • Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
  • Smoking
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Finland,   France,   Ireland,   Netherlands,   Norway,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT00356421
Other Study ID Numbers  ICMJE A2171035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP