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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134147
First Posted: August 24, 2005
Last Update Posted: April 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by:
Pfizer
August 22, 2005
August 24, 2005
April 17, 2008
April 2005
Not Provided
Glycosylated hemoglobin
Same as current
Complete list of historical versions of study NCT00134147 on ClinicalTrials.gov Archive Site
  • 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
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
Not Provided
Not Provided
 
A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
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
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus
Drug: Inhaled Insulin
Not Provided
Freemantle N, Strack TR; Real World Trialists. Will availability of inhaled human insulin (Exubera) improve management of type 2 diabetes? The design of the Real World trial. Trials. 2006 Aug 10;7:25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
May 2007
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Asthma, COPD
  • Smoking
Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT00134147
A2171018
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Sanofi
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

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