Efficacy and safety of nateglinide in type 2 diabetic patients with modest fasting hyperglycemia.

Abstract

Nateglinide is a fast-acting insulin secretion agent that specifically targets postprandial hyperglycemia in patients with type 2 diabetes. The recent reduction in the diagnostic criteria for diabetes and improved understanding of the importance of early insulin secretion served as the rationale for this multicenter, double-blind, randomized, parallel-group, 24-wk study performed in 675 patients with type 2 diabetes but only moderately elevated fasting plasma glucose (FPG) (FPG = 7.0-8.3 mmol/liter) to assess the efficacy and safety of three fixed doses of nateglinide (30, 60, or 120 mg, with meals). A substudy of the effects on early insulin release and prandial glucose excursions following a standardized breakfast was performed in 127 subjects. Nateglinide was well tolerated and elicited a dose-dependent reduction of placebo-adjusted hemoglobin A(1c) (Delta = -0.26 to -0.39%) and FPG (Delta = -0.51 to -0.73 mmol/liter) accompanied by a dose-related increase in suspected hypoglycemic episodes. However, confirmed hypoglycemia occurred in only 5.3% of patients treated with the highest dose, compared with 1.2% in placebo-treated patients (P < 0.05). Nateglinide increased early insulin release and reduced prandial glucose excursions (P < 0.05 vs. placebo). In sum, nateglinide is a safe and effective therapeutic option for treatment of patients with mild to moderate fasting hyperglycemia.

• Authors: Carola Saloranta, Kenneth Hershon, Michele Ball, Sheila Dickinson, David Holmes
• Journal: The Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 87 Issue 9 Pg. 4171-6 (Sep 2002) ISSN: 0021-972X [Print] United States
• PMID: 12213867 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Blood Glucose
• Cyclohexanes
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin
• Nateglinide
• Phenylalanine

Topics

• Adult
• Blood Glucose (drug effects, metabolism)
• Cyclohexanes (adverse effects, therapeutic use)
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Double-Blind Method
• Fasting
• Female
• Glycated Hemoglobin (metabolism)
• Humans
• Hyperglycemia (drug therapy, etiology)
• Hypoglycemia (epidemiology)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Incidence
• Insulin (blood, metabolism)
• Insulin Secretion
• Male
• Nateglinide
• Phenylalanine (adverse effects, analogs & derivatives, therapeutic use)
• Racial Groups
• Treatment Outcome