Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 1 Diabetes Mellitus.
|ClinicalTrials.gov Identifier: NCT00424437|
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 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 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 Therapy in Subjects With Type 1 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial|
|Study Start Date :||September 1999|
|Study Completion Date :||September 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424437
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|