Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00424333
First received: January 17, 2007
Last updated: February 9, 2007
Last verified: February 2007
  Purpose

To determine in subjects with Type 1 Diabetes Mellitus:

  1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin.
  2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: Inhaled human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin in an Intensive Insulin Regimen for Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Primary outcome is 24 week change in baseline in HbA1c.

Secondary Outcome Measures:
  • The secondary endpoints include the following efficacy assessments:
  • Incidence of hypoglycemia
  • Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%)
  • Change from baseline in fasting lipid profile
  • Change from baseline in fasting plasma glucose level
  • Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose)
  • Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study).
  • Change from baseline in body weight
  • Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments).
  • Patient satisfaction and preference.

Estimated Enrollment: 320
Study Start Date: May 1999
Estimated Study Completion Date: October 2000
  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 Diabetes for more than 1 year
  • Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

  • Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
  • Subjects on insulin pump during 2 months prior to screening.
  • Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424333

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Duarte, California, United States
Pfizer Investigational Site
Long Beach, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Stanford, California, United States
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Hollywood, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Tallahassee, Florida, United States
United States, Illinois
Pfizer Investigational Site
Peoria, Illinois, United States
Pfizer Investigational Site
Skokie, Illinois, United States
United States, Maryland
Pfizer Investigational Site
Lutherville, Maryland, United States
United States, Massachusetts
Pfizer Investigational Site
Waltham, Massachusetts, United States
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States
United States, Missouri
Pfizer Investigational Site
Columbia, Missouri, United States
United States, New York
Pfizer Investigational Site
Bronx, New York, United States
Pfizer Investigational Site
New Hyde Park, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Syracuse, New York, United States
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Winston-salem, North Carolina, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
United States, Vermont
Pfizer Investigational Site
Burlington, Vermont, United States
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States
Pfizer Investigational Site
Charlottsville, Virginia, United States
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada
Pfizer Investigational Site
Mississauga, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00424333     History of Changes
Other Study ID Numbers: 217-107
Study First Received: January 17, 2007
Last Updated: February 9, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014