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Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.

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

To determine, in subjects with Type 1 Diabetes Mellitus:

  1. Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day.
  2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, 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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in 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: September 1999
Estimated Study Completion Date: September 2000

Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00424437

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United States, California
Pfizer Investigational Site
Burlingame, California, United States
Pfizer Investigational Site
Irvine, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
San Diego, California, United States
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San Francisco, California, United States
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Tustin, California, United States
United States, Connecticut
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Hartford, Connecticut, United States
United States, District of Columbia
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Washington, District of Columbia, United States
United States, Georgia
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Atlanta, Georgia, United States
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Stockbridge, Georgia, United States
United States, Illinois
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Chicago, Illinois, United States
United States, Kentucky
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Lexington, Kentucky, United States
United States, Missouri
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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St. Louis, Missouri, United States
United States, Nebraska
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Omaha, Nebraska, United States
United States, New Mexico
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Albuquerque, New Mexico, United States
United States, New York
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Buffalo, New York, United States
Pfizer Investigational Site
Manhasset, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
United States, North Carolina
Pfizer Investigational Site
Greenville, North Carolina, United States
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
United States, Virginia
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Charlottesville, Virginia, United States
United States, Washington
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Renton, Washington, United States
Canada, Alberta
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Calgary, Alberta, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
Pfizer Investigational Site
Laval, Quebec, Canada
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00424437     History of Changes
Other Study ID Numbers: 217-106
Study First Received: January 17, 2007
Last Updated: February 9, 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017