Starlix Clinical Trials and Studies
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Starlix Clinical Trials and Studies
A total of 3164 patients were randomized in eight double-blind, placebo- or active-controlled studies 8 to 24 weeks in duration to evaluate the safety and efficacy of Starlix (nateglinide). 3118 patients had efficacy values beyond baseline. In these studies Starlix was administered up to 30 minutes before each of three main meals daily.
Starlix Monotherapy Compared to Placebo
In a randomized, double-blind, placebo-controlled, 24-week study, patients with Type 2 diabetes with HbA 1C = 6.8% on diet alone were randomized to receive either Starlix (60 mg or 120 mg three times daily before meals) or placebo. Baseline HbA 1C ranged from 7.9% to 8.1% and 77.8% of patients were previously untreated with oral antidiabetic therapy. Patients previously treated with antidiabetic medications were required to discontinue that medication for at least 2 months before randomization. The addition of Starlix before meals resulted in statistically significant reductions in mean HbA 1C and mean fasting plasma glucose (FPG) compared to placebo. The reductions in HbA 1C and FPG were similar for patients naive to, and those previously exposed to, antidiabetic medications.
In this study, one episode of severe hypoglycemia (plasma glucose < 36 mg/dL) was reported in a patient treated with Starlix 120 mg three times daily before meals. No patients experienced hypoglycemia that required third party assistance. Patients treated with Starlix had statistically significant mean increases in weight compared to placebo (see Table 1).
In another randomized, double-blind, 24-week, active- and placebo-controlled study, patients with Type 2 diabetes were randomized to receive Starlix (120 mg three times daily before meals), metformin 500 mg (three times daily), a combination of Starlix 120 mg (three times daily before meals) and metformin 500 mg (three times daily), or placebo. Baseline HbA 1C ranged from 8.3% to 8.4%. Fifty-seven percent of patients were previously untreated with oral antidiabetic therapy. Starlix monotherapy resulted in significant reductions in mean HbA 1C and mean FPG compared to placebo that were similar to the results of the study reported above.
Starlix Monotherapy Compared to Other Oral Antidiabetic Agents
Glyburide
In a 24-week, double-blind, active-controlled trial, patients with Type 2 diabetes who had been on a sulfonylurea for = 3 months and who had a baseline HbA 1C = 6.5% were randomized to receive Starlix (60 mg or 120 mg three times daily before meals) or glyburide 10 mg once daily. Patients randomized to Starlix had significant increases in mean HbA 1C and mean FPG at endpoint compared to patients randomized to glyburide.
Metformin
In another randomized, double-blind, 24-week, active- and placebo-controlled study, patients with Type 2 diabetes were randomized to receive Starlix (120 mg three times daily before meals), metformin 500 mg (three times daily), a combination of Starlix 120 mg (three times daily before meals) and metformin 500 mg (three times daily), or placebo. Baseline HbA 1C ranged from 8.3% to 8.4%. Fifty-seven percent of patients were previously untreated with oral antidiabetic therapy. The reductions in mean HbA 1C and mean FPG at endpoint with metformin monotherapy were significantly greater than the reductions in these variables with Starlix monotherapy (see Table 2). Relative to placebo, Starlix monotherapy was associated with significant increases in mean weight whereas metformin monotherapy was associated with significant decreases in mean weight. Among the subset of patients naive to antidiabetic therapy, the reductions in mean HbA 1C and mean FPG for Starlix monotherapy were similar to those for metformin monotherapy (see Table 2). Among the subset of patients previously treated with other antidiabetic agents, primarily glyburide, HbA 1C in the Starlix monotherapy group increased slightly from baseline, whereas HbA 1C was reduced in the metformin monotherapy group.
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