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
  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 3

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 121 Study Locations
Sponsors and Collaborators
Pfizer
Sanofi
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014