Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00424437
First received: January 17, 2007
Last updated: February 9, 2007
Last verified: February 2007
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Purpose
To determine, in subjects with Type 1 Diabetes Mellitus:
- 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.
- 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 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 Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Insulin human
U.S. FDA Resources
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 |
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: 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 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States | |
| Pfizer Investigational Site | |
| Tustin, California, United States | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Hartford, Connecticut, United States | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States | |
| Pfizer Investigational Site | |
| Stockbridge, Georgia, United States | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Columbia, Missouri, United States | |
| Pfizer Investigational Site | |
| St Louis, Missouri, United States | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States | |
| United States, New Mexico | |
| Pfizer Investigational Site | |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| Pfizer Investigational Site | |
| Buffalo, New York, United States | |
| Pfizer Investigational Site | |
| Manhasset, New York, United States | |
| Pfizer Investigational Site | |
| New Hyde Park, New York, United States | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States | |
| Pfizer Investigational Site | |
| Irving, Texas, United States | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Charlottesville, Virginia, United States | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Renton, Washington, United States | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada | |
| Canada, Newfoundland and Labrador | |
| Pfizer Investigational Site | |
| 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
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00424437 History of Changes |
| Other Study ID Numbers: | 217-106 |
| 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 June 18, 2013