A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
NCT00356421
Last updated date
ABOUT THIS STUDY
To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes
mellitus
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Diabetes mellitus Type 1
Exclusion Criteria
Show details
- Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
- Smoking
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Type 1 Diabetes MellitusStudy to Estimate the Effects of Inhaled Versus Intravenous (IV) Infusion of Human Insulin in Subjects With Type 1 Diabetes
NCT00315952
- Pittsburgh, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Type 1 Diabetes MellitusUVA Islet Cell Transplantation in Patients With Type I Diabetes
NCT00605592
- Charlottesville, Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Type 1 Diabetes MellitusPositron Emission Tomography (PET) Imaging of Pancreatic Beta-Cell Mass in Healthy and Type 1 Diabetic Patients
NCT00958997
- New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Type 1 Diabetes MellitusSafety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
NCT00479258
- Buffalo, New York
ALL GENDERS
6 Years+
years
MULTIPLE SITES
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 |
| |||
Study Arms ICMJE |
| |||
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 | 58 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |