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One 24-week, randomized, double-blind, placebo-controlled study of 701 patients with type 2 diabetes evaluated the effects of Starlix, metformin, and the combination of Starlix with metformin on glycemic control, including postprandial glucose control, and assessed the tolerability and safety of these treatment regimens.
The study reported that Starlix effectively controlled mealtime glucose spikes and reduced overall glucose levels as measured by HbA1c. Researchers concluded that the combination of Starlix and metformin was complementary and resulted in even greater reductions in HbA1c than either agent alone. In all studies, Starlix was well-tolerated with an overall safety profile comparable to placebo.
Low blood sugar, or hypoglycemia, in 2. In clinical trials, only 0. Product Information Starlix is marketed by Novartis Pharmaceuticals Corporation and is the company's first drug for the treatment of type 2 diabetes. For most patients, the recommended starting and maintenance dose of Starlix alone or in combination with metformin is 120 mg, three times daily before meals.
Yamanouchi and Hoechst Marion Roussel market the product in Japan under brand names Starsis or Fastic. Novartis licenses Starlix from Ajinomoto Co. About Diabetes "Starlix provides physicians with a significant new tool to fight diabetes, an extremely serious disease affecting millions in this country alone," said Dr.
Of the approximately 16 million Americans who have diabetes, 90-95 percent have type 2 diabetes.
In another randomized, double-blind, 24-week, active- and placebo-controlled study, patients with Type 2 diabetes were randomized to receive nateglinide 120 mg three times daily before mealsmetformin 500 mg three times dailya combination of nateglinide 120 mg three times daily before meals and metformin 500 mg three times dailyor placebo. Baseline HbA1C ranged from 8. Fiftyseven percent of patients were previously untreated with oral antidiabetic therapy.
Nateglinide monotherapy resulted in significant reductions in mean HbA1C and mean FPG compared to placebo that were similar to the results of the study reported above see Table 2.
Patients randomized to nateglinide had significant increases in mean HbA1C and mean FPG at endpoint compared to patients randomized to glyburide. Patients previously treated with antidiabetic medications were required to discontinue medication for at least 2 months before randomization.
The reductions in mean HbA1C and mean FPG at endpoint with metformin monotherapy were significantly greater than the reductions in these variables with nateglinide monotherapy see Table 2.
Relative to placebo, nateglinide 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 previously treated with other antidiabetic agents, primarily glyburide, HbA1C in the nateglinide monotherapy group increased slightly from baseline, whereas HbA1C was reduced in the metformin monotherapy group see Table 2.
In the active and placebo-controlled study of metformin and nateglinide described above, the combination of nateglinide and metformin resulted in statistically significantly greater reductions in HbA1C and FPG compared to either nateglinide or metformin monotherapy see Table2.
Nateglinide, alone or in combination with metformin, significantly reduced the prandial glucose elevation from premeal to 2-hours post-meal compared to placebo and metformin alone.
No patient experienced an episode of hypoglycemia that required third party assistance. Compared to placebo, nateglinide monotherapy was associated with a statistically significant increase in weight, while no significant change in weight was observed with combined nateglinide and metformin therapy see Table2. Combination therapy with nateglinide and metformin was associated with statistically significantly greater reductions in HbA1C compared to metformin monotherapy -0. The addition of nateglinide 120 mg three times per day with meals was associated with statistically significantly greater reductions in HbA1Ccompared to rosiglitazone monotherapy.
How should I take Buy Starlix Online?
If you are taking other diabetes medications, have consumed alcohol, or have other medical conditions that cause low blood glucose e. Consult your doctor for advice about whether any special monitoring is necessary.
Pregnancy: This medication should not be used during pregnancy. If you think you may be pregnant or if you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if nateglinide passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby.
Talk to your doctor about whether you should continue breast-feeding. Children: The safety and effectiveness of using this medication have not been established for children.
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We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Skip to Main Content U. National Library of Medicine U. Download DRUG LABEL INFO: PDF XML Official Label Printer Friendly View All SectionsClose All Sections These highlights do not include all the information needed to use STARLIX safely and effectively. See full prescribing information for STARLIX.
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Novartis filed a New Drug Application with the Food and Drug Administration on December 21, 1999. It typically takes the FDA two years to approve an NDA, although it can range from two months to seven years. Biggs thinks that Novartis hopes to launch the drug by November 2000. In August 1999 two companies launched the drug in Japan. The safety and efficacy of Starlix look good. More than 3,700 people with type 2 diabetes participated in the tests of using it alone or in conjunction with metformin Glucophage for even better glucose control.
Starlix comes from the amino acid phenylalanine and has a different chemical and pharmacological structure from the other drugs available for controlling blood glucose. While several people have speculated that it is in the same class of drugs as Prandin, the company and researchers who have studied it maintain that it is a new class entirely.
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What questions should I ask my doctor about this prescription.
Early this year, the Food and Drug Administration asked Parke-Davis to remove Rezulin from the market.
Generic Starlix is made by various different manufacturers, such as: Is Generic Nateglinide as Good as Starlix. All generic medications must undergo certain tests to compare them to brand-name medications. Food and Drug Administration FDA then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns each generic a rating.
Where can I get more information?
A drug prescribed for the treatment of type 2 diabetes.
Race Results of a population pharmacokinetic analysis including subjects of Caucasian, Black, and other ethnic origins suggest that race has little influence on the pharmacokinetics of nateglinide.