Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
This study has been completed.
Information provided by:
First received: January 17, 2007
Last updated: February 9, 2007
Last verified: February 2007
To determine, in subjects with Type 2 Diabetes Mellitus:
- Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day.
- The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.
Diabetes Mellitus, Type 2
Drug: Inhaled human insulin (EXUBERA™)
|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 Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial|
Resource links provided by NLM:
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.
|Study Start Date:||September 1999|
|Estimated Study Completion Date:||December 2000|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424411
Show 46 Study Locations
Show 46 Study Locations
Sponsors and Collaborators
|Study Director:||Pfizer CT.gov Call Center||Pfizer|