Aggressive insulin therapy for tight glycemic control has been slow to gain acceptance in the clinical setting. One limitation is the inconvenience and poor subject acceptability of injection therapy, especially in a multiple daily injection regimen. In addition, the traditional dosing of pre-meal Regular insulin, 30 to 45 minutes before eating, to obtain optimal postprandial control is inconvenient. The present study is designed to evaluate pre-meal pulmonary delivery of insulin in subjects with Type 2 diabetes mellitus who are currently being treated with combination NPH and Regular insulin. The purpose is to determine: 1) 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 conventional subcutaneous insulin regimen involving 2 mixed NPH/Regular injection per day; 2) the toleration and safety of inhaled insulin therapy and its effects after 6 months, if any, on measures of pulmonary function.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR007122-09
Application #
6408662
Study Section
General Clinical Research Centers Committee (CLR)
Project Start
1992-09-30
Project End
2001-02-28
Budget Start
Budget End
Support Year
9
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Type
DUNS #
041418799
City
Winston-Salem
State
NC
Country
United States
Zip Code
27106
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