Efficacy and Safety of Nateglinide in Type 2 Diabetic Patients with Modest Fasting Hyperglycemia

• Published in: The journal of clinical endocrinology and metabolism 2002-09, Vol.87 (9), p.4171-4176
• Main Authors: Saloranta, Carola, Hershon, Kenneth, Ball, Michele, Dickinson, Sheila, Holmes, David
• Format: Article
• Language: English
• Subjects: Adult; Biological and medical sciences; Blood Glucose - drug effects; Blood Glucose - metabolism; Continental Population Groups; Cyclohexanes - adverse effects; Cyclohexanes - therapeutic use; Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Double-Blind Method; Drug toxicity and drugs side effects treatment; Fasting; Female; General and cellular metabolism. Vitamins; Glycated Hemoglobin A - metabolism; Humans; Hyperglycemia - drug therapy; Hyperglycemia - etiology; Hypoglycemia - epidemiology; Hypoglycemic Agents - adverse effects; Hypoglycemic Agents - therapeutic use; Incidence; Insulin - blood; Insulin - metabolism; Insulin Secretion; Male; Medical sciences; Miscellaneous (drug allergy, mutagens, teratogens...); Nateglinide; Pharmacology. Drug treatments; Phenylalanine - adverse effects; Phenylalanine - analogs & derivatives; Phenylalanine - therapeutic use; Treatment Outcome
• ISSN: 0021-972X; 1945-7197
• DOI: 10.1210/jc.2002-020068

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 A1c (Δ = −0.26 to −0.39%) and FPG (Δ = −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.