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

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ClinicalTrials.gov Identifier: NCT00367445
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : January 29, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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
Study Start Date : September 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine





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

Secondary Outcome Measures :
  1. Insulin pharmacokinetics


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diabetes mellitus Type 2

Exclusion Criteria:

  • Severe Asthma, severe COPD
  • Smoking

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00367445     History of Changes
Other Study ID Numbers: A2171094
First Posted: August 22, 2006    Key Record Dates
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