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

This study has been completed.

First Received: August 22, 2005 Last Updated: April 16, 2008 History of Changes

Sponsors and Collaborators:	Pfizer Sanofi-Aventis
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00134147

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Inhaled Insulin	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Glycosylated hemoglobin

Secondary Outcome Measures:

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

Estimated Enrollment:	1100
Study Start Date:	April 2005
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Asthma, COPD
Smoking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134147

Show 121 Study Locations

Sponsors and Collaborators

Pfizer

Sanofi-Aventis

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A2171018
Study First Received:	August 22, 2005
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00134147 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009