71 (2.9)

A second 6- month, double-blind, placebo-controlled study in insulin-treated type II diabetics who previously were poorly controlled on oral agents receiving 30 to 150 units insulin/day assessed the use of Rezulin in reducing exogenous insulin dosage while improving glycemic control as measured by capillary blood glucose.

Patients treated with 200 mg (N= 75) and 400 mg (N= 76) Rezulin had their insulin doses decreased by 41% and 58%, respectively, compared to a reduction of insulin dose in the placebo group (N= 71) of 14% while maintaining or improving glycemic control. Forty-one percent of the patients in the 400 mg group decreased their insulin injection frequency an average from 3 to 1 injections per day; 19% of patients receiving placebo decreased their injection frequency an average from 3 to 2 injections per day. Insulin therapy was discontinued in 15% of patients in the 400 mg Rezulin group compared to 7% in the 200 mg group and 1.5% in the placebo group.

A greater than 50 % reduction in insulin dose was achieved by 51% of patients on 200 mg and 70% on 400 mg once daily as compared to 17% on placebo.

Monotherapy: Three clinical trials, including 2 placebo-controlled studies with durations from 12 to 26 weeks have been conducted to study the use of Rezulin as monotherapy. These studies have examined Rezulin doses from 100 to 600 mg/day in approximately 1500 patients. The patients studied have included patients previously treated with a sulfonylurea who were studied following prior therapy wash out (N= 1265) and patients previously treated with diet only (N= 230). In patients previously treated with a sulfonylurea, Rezulin treatment did not result in an improvement in glycemic control beyond that seen with the patients prior therapy although glucose lowering was significantly better than that seen with placebo treatment for patients previously treated with diet, Rezulin doses of 200 mg, 400 mg and 600 mg/day were associated with improved FSG compared to placebo. However, only the 600 mg/day dose resulted in a difference compared with placebo that was statistically significant in both studies (see Table 5). At 600 mg per day, 58% of patients previously treated with diet in the 12-week study and 47% of patients previously treated with diet in the 26-week study (versus placebo values of 28% 280s and 21%, respectively) had a response to Rezulin of > 30 mg/dL reduction from baseline in fasting serum glucose.

Glycemic Parameters in Diet-Failure Patients
	12 Week Study
	Placebo	200	400	600
N	19	23	20	33
FSG (mg/ dL)
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