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)
Multicentre, double-blind, randomized study of mitiglinide compared with nateglinide in type 2 diabetes mellitus patients in China. [2009.05]
This study investigated the non-inferiority of mitiglinide 10 - 20 mg versus nateglinide 120 mg, given orally three times daily for 20 weeks, in 291 Chinese type 2 diabetes mellitus (DM) patients in whom adequate blood glucose control had not been achieved by diet and exercise... In conclusion, mitiglinide 10 - 20 mg three times daily provided similar blood glucose control to nateglinide 120 mg three times daily in type 2 DM patients, including the elderly and patients with mild diabetes mellitus.
[A comparison of efficacy and tolerance of nateglinide and acarbose monotherapy in type 2 diabetes mellitus] [2009.04]
OBJECTIVE: To compare the efficacy and tolerability of nateglinide with those of acarbose in Chinese type 2 diabetes mellitus (T2DM) patients... CONCLUSIONS: Nateglinide (120 mg, 3/d) is effective and well tolerated in T2DM patients uncontrolled by diet, demonstrating similar HbA1c reductions as compared with acarbose (100 mg, 3/d).
Nateglinide combination therapy with basal insulin and metformin in patients with Type 2 diabetes. [2009.04]
CONCLUSIONS: Addition of a short-acting insulin secretagogue at main meals improves postprandial hyperglycaemia during combination therapy with basal insulin and metformin, but increases the frequency of hypolycaemia.
Improvement of glycaemic control by nateglinide decreases systolic blood pressure in drug-naive patients with type 2 diabetes. [2008.03]
BACKGROUND: It has been speculated that oral hypoglycaemic agents that block K-ATP channels could potentially increase blood pressure by blocking such channels in vascular myocytes. No information about this issue exists regarding nateglinide... CONCLUSIONS: In drug-naive patients with type 2 diabetes, the improvement in glycaemic control with nateglinide is associated with a decrease in systolic blood pressure.
Nateglinide reduces carotid intima-media thickening in type 2 diabetic patients under good glycemic control. [2007.11]
CONCLUSION: In type 2 diabetic patients with good glycemic control, further strict glycemic control by nateglinide results in regression of carotid intima-media thickness.
Clinical Trials Related to Starlix (Nateglinide)
Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients [Completed]
The objective of the present study is to evaluate both the efficacy and safet of nateglinide
in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose
tolerance. Primarily will the change in glucose tolerance and acute insuline responce be
addressed.
Study of the Durability of Glycemic Control With Nateglinide [Not yet 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.
A Pilot Study to Evaluate the Effects of Nateglinide Vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion [Completed]
The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients [Completed]
In type 2 diabetic patients, tight blood glucose control often requires both fasting and
post-prandial glucose control separately. In the diabetic patients already on the insulin
glargine treatment for the control of fasting blood glucose, additional measures for the
control of post-prandial glucose level are often required. Nateglinide and acarbose are
frequently used for this purpose. We hypothesized that the short acting sulfonylurea
"nateglinide" may be more efficacious in diabetic patients with appreciable endogenous
insulin secretion, while acarbose may be more efficacious in patients with lower endogenous
insulin secretion. And we also want to clarify the clinical and biochemical parameters that
can predict the responsiveness to each agent in this multi-center randomized open cross-over
clinical study.
Effects of Nateglinide vs. Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia and Inflammatory Factors [Recruiting]
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