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

J Clin Endocrinol Metab. 2002 Sep;87(9):4171-6. doi: 10.1210/jc.2002-020068.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • 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
  • Fasting
  • Female
  • 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
  • Nateglinide
  • Phenylalanine / adverse effects
  • Phenylalanine / analogs & derivatives*
  • Phenylalanine / therapeutic use*
  • Treatment Outcome

Substances

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