Not Signed In -
Insulin aspart |
Humalog Aspart; Humulin Aspart; insulin aspart [rDNA origin]; Novolin Aspart; NovoLog |
Clinical Trial: Efficacy and Safety of Inhaled Insulin Compared with Subcutaneous Human Insulin Therapy in Adults with Type 1 Diabetes
This study is no longer recruiting patients.
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Purpose
This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with Type 1 diabetes mellitus. The drug is called EXUBERA® (inhaled insulin).
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus | Drug: Inhaled Insulin | Phase III |
MedlinePlus related topics: Diabetes
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Exubera® (Inhaled Insulin) Compared with Subcutaneous Human Insulin Therapy in Adult Subjects with Type 2 Diabetes Mellitus: A Long-Term, Outpatient, Open-Label, Parallel-Group Comparative Trial
Further Study Details:
Primary Outcomes: The primary outcome is to assess the toleration and safety of EXUBERA® (inhaled insulin) compared to subcutaneous insulin therapy the effects if any on measures of pulmonary function.
Secondary Outcomes: Secondary endpoints include HbA1c, fasting plasma glucose, body weight, lipids, insulin dose, incidence and severity off hypoglycemic episodes, cough questionnaire, and baseline and transition dyspnea index.
Expected Total Enrollment: 600
Secondary Outcomes: Secondary endpoints include HbA1c, fasting plasma glucose, body weight, lipids, insulin dose, incidence and severity off hypoglycemic episodes, cough questionnaire, and baseline and transition dyspnea index.
Expected Total Enrollment: 600
Study start: May 2002
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Location Information
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A2171022
Last Updated: August 26, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00137046
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: August 26, 2005
Record first received: August 26, 2005
ClinicalTrials.gov Identifier: NCT00137046
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Humalog Aspart (Drug Digest)
- Humulin Aspart (Drug Digest)
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