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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00367445
First received: August 21, 2006
Last updated: January 25, 2008
Last verified: January 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus Type 2

Exclusion Criteria:

  • Severe Asthma, severe COPD
  • Smoking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00367445     History of Changes
Other Study ID Numbers: A2171094
Study First Received: August 21, 2006
Last Updated: January 25, 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
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014