Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00424333
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 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.
- 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:
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: | 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
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| 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 May 23, 2013