TITRATION EVALUATION OF GLIPIZIDE GITS FOR NIDDM

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PURPOSE:The purpose of the current study is to assess the effect of titration of glipizide GITS at 4 month intervals on hemoglobin A1c levels. Previous fixed dose studies of glipizide GITS, a long-acting and daily dosed oral hypoglycemic agent for the treatment of type II diabetes, have demonstrated that no dose-response relationship exists between hemoglobin A1c and doses of GITS ranging from 5-60 mg. Conversely, a dose-response relationship was observed with fasting plasma glucose and doses ranging from 5-20mg. However, the duration of treatment at assigned doses was limited to 8 weeks. New data from the literature has indicated that decreases in hemoglobin A1c lag significantly behind decreases in fasting plasma glucose, and the appropriate time interval to observe stable hemoglobin A1c levels is 4 months. METHODS: This is a phase IV, open-label, multicenter study which will evaluate 75 patients (total # for all sites) in order to obtain 50 completed patients for evaluation. Patients in this study are started on glipizide GITS 5 mg daily for 4 months. At the end of the 4 month interval, if euglycemia is not achieved, the study medication is increased to the next dosage of 10 mg for 4 months, followed by 20 mg for the remaining 4 months if necessary. Patients are evaluated in a fasting state at the end of each 4 month interval. The tests performed include hemoglobin A1c, lipids, fructosamine, c-peptide, insulin and plasma glucose. Following a standardized breakfast of Sustacal, c-peptide, insulin, and plasma glucose levels are drawn at 30 minute intervals for 3 hours.