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Rezulin

Clinical Pharmacology
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Clinical Pharmacology

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A combination of 200, 400, or 600 mg of Rezulin with micronized glyburide achieved lower levels of fasting plasma glucose and HbA 1C C levels than either agent achieved alone (see Tables 2 and 3). These improvements in glycemic control were associated with mean weight gains of 5.8 to 13.1 pounds. To eliminate weight as a confounding factor in this study. patients had been instructed to follow a diet to maintain current weight.

Combination With Insulin: Two clinical studies were conducted to evaluate the effects of Rezulin on glycemic control and insulin dose in patients with type II diabetes who were being treated with insulin.

In one 6-month, double-blind, placebo-controlled study in insulin-treated type II diabetic patients receiving a mean of 73 (range 27- l43) units/day of insulin with a mean baseline HbA 1C of 9.42 (range 7.04-12.48), Rezulin (200 or 600 mg/day) or placebo was added to the insulin therapy. Investigators were instructed to reduce insulin doses only if two consecutive FSGs were <100 mg/dL. Rezulin-treated patients showed a significant (p< 0.000l ) reduction in HbA1C compared with patients who received placebo (see Table 4).

Thirty percent of patients treated with 200 mg Rezulin and 57% of patients treated with 600 mg Rezulin had an HbA 1C value below 8 % at the end of the study compared with 11% of placebo treated patients. Accompanying this improvement in glycemic control was a significant (p< 0. 0001) decrease in exogenous Insulin dosage of 15% in the 200 mg Rezulin treatment group and 42% in the 600 mg Rezulin treatment group compared with 1% in the placebo group HbA 1C values and Insulin dose as a function of duration of Rezulin treatment.

TABLE 4.  

Combination Therapy with Insulin:

Mean Change From Baseline at 6 Months

 

Troglitazone

Parameter

Placebo

200 mg

600 mg

N

118

116

116

HbA 1C (%)
Mean Baseline (SE)

9.43 (0.10)

9.51 (0.10)

9.32 (0.11)

Mean Change From Baseline (SE) 1

-0.12 (0.10)

-0.84 (0.10)

-1.41 (0.10)

Adjusted Mean Difference From Placebo (SE)

--

-0.72 (0.14)"

-1.29 (0.14)*

Percent Mean Change From Baseline

-1.3

-8.8

-15.1

Insulin daily dosage (units)
Mean Baseline (SE)

75 (3.3)

73 (3.4)

Brand Name: Rezulin
Generic Name: Troglitazone (removed from the US market 3/21/00)
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