A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

This study has been completed.

Sponsor:

Collaborator:

Sanofi

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00134147

First received: August 22, 2005

Last updated: April 16, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2005

Last Updated Date

April 16, 2008

Start Date ^ICMJE

April 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Glycosylated hemoglobin

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00134147 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percent of patients achieving good control of fasting glucose and lipids
Rate of hypoglycemia
Changes in body weight
Patient satisfaction
Safety based on adverse events reported and laboratory tests

Original Secondary Outcome Measures ^ICMJE

Percent of patients achieving good control of fasting glucose and lipids Rate of hypoglycemia Changes in body weight Patient satisfaction Safety based on adverse events reported and laboratory tests

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

Official Title ^ICMJE

A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents

Brief Summary

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: Inhaled Insulin

Study Arm (s)

Not Provided

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

Completed

Enrollment ^ICMJE

1100

Completion Date

May 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diabetes mellitus Type 2
Failing two or more oral anti-diabetic agents

Exclusion Criteria:

Asthma, COPD
Smoking

Gender

Both

Ages

35 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, France, Germany, Italy, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00134147

Other Study ID Numbers ^ICMJE

A2171018

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2008

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

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