Six Month Clinical Trial Assessing Efficacy and Safety of Inhaled Insulin in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT00424333|
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : February 13, 2007
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 or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: Inhaled human insulin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 1999|
|Study Completion Date :||October 2000|
- Primary outcome is 24 week change in baseline in HbA1c.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424333
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|