A Clinical Trial Assessing the Impact of Inhaled Insulin... | NCT00287066

Studies
A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition

NCT00287066

Sponsor

Pfizer

Status

Terminated

Last Update Posted

Feb 21, 2008Estimated

Enrollment

Phase

Phase 3

Conditions

Diabetes Mellitus

Interventions

Inhaled Human Insulin
Regular Human Insulin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

See termination reason in detailed description.

Expanded Access Info

Not provided

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Feb 2, 2006

First Submission Date that Met QC Criteria

Feb 2, 2006

First Posted Date

Feb 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2008

Last Update Posted Date

Feb 21, 2008Estimated

Description Module

Brief Summary

To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes

Detailed Description

The study was terminated on Oct. 28, 2007. The protocol was undergoing implementation and methodological issues with major revisions that qualified this trial as a new trial. Pfizer decided to cancel new trials because of the decision to withdraw Exubera due to lack of market performance and not for safety reasons.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
18F-labeled glucose uptake in muscle

Measure	Description	Time Frame
Glucose turnover overnight Insulin pharmacokinetics

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes mellitus Type 1

Exclusion Criteria:

Asthma, COPD
Smoking

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Pittsburgh	Pennsylvania		United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007328	Insulin

Ancestor Terms

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Inhaled Human Insulin	Drug
Regular Human Insulin	Drug