Starlix Combination Therapy: 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 HbA1C ranged from 8.3% to 8.4%. Fifty-seven percent of patients were previously untreated with oral antidiabetic therapy. Patients previously treated with antidiabetic medications were required to discontinue medication for at least 2 months before randomization. The combination of Starlix and metformin resulted in statistically significantly greater reductions in HbA1C and FPG compared to either Starlix or metformin monotherapy. Starlix, alone or in combination with metformin, significantly reduced the prandial glucose elevation from pre-meal to 2-hours post-meal compared to placebo and metformin alone.
In this study, one episode of severe hypoglycemia (plasma glucose ? 36 mg/dL) was reported in a patient receiving the combination of Starlix and metformin and four episodes of severe hypoglycemia were reported in a single patient in the metformin treatment arm. No patient experienced an episode of hypoglycemia that required third party assistance. Compared to placebo, Starlix monotherapy was associated with a statistically significant increase in weight, while no significant change in weight was observed with combined Starlix and metformin therapy.
In another 24-week, double-blind, placebo-controlled trial, patients with Type 2 diabetes with HbA1C? 6.8% after treatment with metformin (? 1500 mg daily for ? 1 month) were first entered into a four week run-in period of metformin monotherapy (2000 mg daily) and then randomized to receive Starlix (60 mg or 120 mg three times daily before meals) or placebo in addition to metformin. Combination therapy with Starlix and metformin was associated with statistically significantly greater reductions in HbA1C compared to metformin monotherapy (-0.4% and -0.6% for Starlix 60 mg and Starlix 120 mg plus metformin, respectively).
Starlix Combination Therapy: Rosiglitazone
A 24-week, double blind multicenter, placebo-controlled trial was performed in patients with Type 2 diabetes not adequately controlled after a therapeutic response to rosiglitazone monotherapy 8 mg daily. The addition of Starlix (120 mg three times per day with meals) was associated with statistically significantly greater reductions in HbA1C compared to rosiglitazone monotherapy. The difference was -0.77% at 24 weeks. The mean change in weight from baseline was about +3 kg for patients treated with Starlix plus rosiglitazone vs about +1 kg for patients treated with placebo plus rosiglitazone.
Starlix Combination Therapy: Glyburide
In a 12-week study of patients with Type 2 diabetes inadequately controlled on glyburide 10 mg once daily, the addition of Starlix (60 mg or 120 mg three times daily before meals) did not produce any additional benefit.
Most important information about Starlix
More information about STARLIX (Nateglinide) :
Starlix approved for use in combination with thiazolidinedione class of antidiabetic drugs
Study: Starlix enhances glucose control in people with impaired tolerance
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Tags: Conditions & Treatments, Medications, Starlix (Nateglinide), Type 2 Diabetes