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A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367445
First Posted: August 22, 2006
Last Update Posted: January 29, 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.
Information provided by:
Pfizer
  Purpose
To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: Inhaled Human Insulin (Exubera) Drug: Insulin Glargine (Lantus) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 1 Month, Open-Label Inpatient, Randomized Cross-Over Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On 24-Hour Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Oral Agents

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Variability of blood glucose over a period of 72 hours

Secondary Outcome Measures:
  • Insulin pharmacokinetics

Estimated Enrollment: 30
Study Start Date: September 2006
Study Completion Date: February 2007
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus Type 2

Exclusion Criteria:

  • Severe Asthma, severe COPD
  • Smoking
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367445


Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00367445     History of Changes
Other Study ID Numbers: A2171094
First Submitted: August 21, 2006
First Posted: August 22, 2006
Last Update Posted: January 29, 2008
Last Verified: January 2008

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