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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hamilton, New Jersey, 08610 United States
Contact
1-800-718-1021
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

NCT00356421
Pfizer
Terminated
A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

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A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
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
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • 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.
  • Active Comparator: Control
    Intervention: Drug: Insulin lispro (Humalog)
  • Experimental: Experimental
    Intervention: Drug: Inhaled Human Insulin (Exubera®)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
58
June 2008
June 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes mellitus Type 1

Exclusion Criteria:

  • Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
  • Smoking
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   Finland,   France,   Ireland,   Netherlands,   Norway,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Germany
 
NCT00356421
A2171035
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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