STARLIX SUMMARY
Starlix® (nateglinide)is an oral antidiabetic agent used in the management of Type 2 diabetes mellitus. Starlix, (-)-N-[(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues.
Starlix® (nateglinide) is indicated as monotherapy to lower blood glucose in patients with Type 2 diabetes (non-insulin dependent diabetes mellitus, NIDDM) whose hyperglycemia cannot be adequately controlled by diet and physical exercise and who have not been chronically treated with other antidiabetic agents.
Starlix is also indicated for use in combination with metformin or a thiazolidinedione. In patients whose hyperglycemia is inadequately controlled with metformin or after a therapeutic response to a thiazolidinedione, Starlix may be added to, but not substituted for, those drugs.
Patients whose hyperglycemia is not adequately controlled with glyburide or other insulin secretagogues should not be switched to Starlix, nor should Starlix be added to their treatment regimen.
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NEWS HIGHLIGHTS
Published Studies Related to Starlix (Nateglinide)
Nateglinide provides tighter glycaemic control than glyburide in patients with Type 2 diabetes with prevalent postprandial hyperglycaemia. [2011.05]
AIMS: Postprandial hyperglycaemia in patients with Type 2 diabetes mellitus has been linked to the development of cardiovascular disease. This study compared the effects of mealtime (thrice-daily) nateglinide with once-daily glyburide on postprandial glucose levels in patients with Type 2 diabetes and postprandial hyperglycaemia... CONCLUSIONS: Nateglinide leads to greater reductions in postprandial glucose excursions and is associated with a lower risk of hypoglycaemia than glyburide in this selected population of patients with Type 2 diabetes. (c) 2011 The Authors. Diabetic Medicine (c) 2011 Diabetes UK.
Additive hypoglycaemic effect of nateglinide and exogenous glucagon-like peptide-1 in type 2 diabetes. [2011.03]
We examined the postprandial glucose regulators nateglinide and GLP-1, separately and in combination, in people with type 2 diabetes. Nateglinide inhibited DPP-4 activity, reduced GLP-1 degradation and enhanced its insulinotropic and blood glucose lowering effect.
[NAVIGATOR: A trial of prevention of cardiovascular complications and type 2 diabetes with valsartan and/or nateglinide] [2010.04]
NAVIGATOR ("Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research") is a large international placebo-controlled trial that randomised 9,031 individuals at high risk because of impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors...
Baseline characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial population: comparison with other diabetes prevention trials. [2010.04]
The Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial is exploring two pharmacological strategies (nateglinide and valsartan, both alone and in combination) in the prevention of overt diabetes mellitus (DM) and the reduction of cardiovascular disease (CVD) in subjects at high risk for these events...
Postprandial endothelial dysfunction in subjects with new-onset type 2 diabetes: an acarbose and nateglinide comparative study. [2010.03.24]
BACKGROUND: Postprandial hyperglycemia is believed to affect vascular endothelial function. The aim of our study was to compare the effects of acarbose and nateglinide on postprandial endothelial dysfunction... CONCLUSIONS: Our results suggest that acarbose improves postprandial endothelial function by improvement of postprandial hyperglycemia, independent of postprandial hyperinsulinemia. Acarbose may thus have more beneficial effects on postprandial endothelial function in patients with type 2 diabetes than nateglinide.
Clinical Trials Related to Starlix (Nateglinide)
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed Condition [Completed]
Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition [Completed]
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications [Completed]
This study is a test of the safety and effectiveness of two drugs, one for diabetes and one
for hypertension, in keeping patients with high lab values of glucose from progressing to
frank diabetes and developing cardiovascular complications. People in this study cannot
have frank diabetes but are considered "borderline" based on blood tests. People in the
study take none, one or both of the drugs and do not know which one(s) they are taking.
Study of the Durability of Glycemic Control With Nateglinide [Recruiting]
This multi-center, randomized controlled study aims to evaluate the durability and efficacy
of nateglinide therapy for long term glycemic control compared with glimepiride.
Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors [Completed]
This study was conducted to demonstrate superiority of nateglinide in postprandial glucose
fluctuation, dyslipidemia, and inflammatory status improvement.
Reports of Suspected Starlix (Nateglinide) Side Effects
Drug Ineffective (4),
Blood Glucose Abnormal (3),
Urinary Tract Infection (3),
Hypoglycaemic Coma (2),
Blood Glucose Increased (2),
Renal Failure Acute (2),
Localised Infection (2),
Metabolic Acidosis (2),
Haematuria (2),
Renal Injury (1), more >>
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Page last updated: 2011-12-09
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