Not Signed In -
Diabetes |
Blood Sugar; Diabetes Mellitus; Non-Insulin Dependent Diabetes Mellitus; Type II Diabetes |
Clinical Trial: Efficacy and Safety of Inhaled Insulin Compared with Subcutaneous Human Insulin Therapy in Adults with Type 2 Diabetes
This study is no longer recruiting patients.
|
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 2 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: Treatment, 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 inhaled insulin compared to subcutaneous insulin therapy and the effects if any on measures of pulmonary function.
Secondary Outcomes: Secondary endpoints include: hbA1c, fasting plasma glucose, body weight, insulin dose, incidence and severity of 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, insulin dose, incidence and severity of hypoglycemic episodes, cough questionnaire, and baseline and transition dyspnea index.
Expected Total Enrollment: 600
Study start: June 2002
Eligibility
Ages Eligible for Study: 35 Years - 75 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: A2171029
Last Updated: August 26, 2005
Record first received: August 25, 2005
ClinicalTrials.gov Identifier: NCT00136916
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 25, 2005
ClinicalTrials.gov Identifier: NCT00136916
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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