Evaluation of a new insulinotropic agent by using an innovative technology: efficacy and safety of nateglinide determined by continuous glucose monitoring

Diabetes Technol Ther. 2004 Feb;6(1):31-7. doi: 10.1089/152091504322783387.

Abstract

Nateglinide, a new insulinotropic agent, specifically targets prandial glycemic excursions. Recently, innovative technologies have become available that provide the possibility to measure 72-h blood glucose values continuously. The aim of this study was to evaluate the effects of nateglinide on 24-h blood glucose profiles in diabetic patients. Eighteen patients with type 2 diabetes mellitus--seven on diet only and 11 on metformin monotherapy--participated in the study. Mean age was 60 years, mean diabetes' duration was 7.4 years, and mean hemoglobin A1c was 8.4%. They underwent a 72-h glucose monitoring using a continuous glucose monitoring system (CGMS, Medtronic MiniMed, Northridge, CA) under their usual diabetes therapy and a standardized breakfast. After this period, therapy with nateglinide, 120 mg three times a day before meals, was initiated. Three days later patients again underwent 72-h glucose monitoring. Mean blood glucose values and mean fasting blood glucose values decreased significantly, from 172 mg/dL before to 131 mg/dL (P< 0.0004) and from 172 mg/dL before to 126 mg/dL (P< 0.0005), respectively, with nateglinide therapy. Postprandial hyperglycemia, expressed as mean blood glucose over a time period of 2 h after a meal, declined significantly after all three daily meals. The number of blood glucose values above 140 mg/dL decreased from 207 without to 98 during nateglinide therapy. Nateglinide was not associated with hypoglycemia or other adverse events. We found in this study, using CGMS, that nateglinide has a glucose-lowering potency that not only affects postprandial hyperglycemia, but also overnight and fasting blood glucose values.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Glucose / metabolism*
  • Blood Glucose Self-Monitoring / methods*
  • Cyclohexanes / adverse effects
  • Cyclohexanes / therapeutic use*
  • Diabetes Mellitus, Type 2 / blood*
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Female
  • Glycated Hemoglobin / metabolism
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Middle Aged
  • Nateglinide
  • Phenylalanine / adverse effects
  • Phenylalanine / analogs & derivatives
  • Phenylalanine / therapeutic use*
  • Postprandial Period / physiology
  • Prospective Studies
  • Statistics, Nonparametric

Substances

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