Effects of Nateglinide on the Control of Mealtime Glucose Excursions in Korean Patients with Type 2 Diabetes

Abstract

Background: Nateglinide belong to a new family of insulin secretagogues that stimulate the early phase of insulin secretion. This study was designed to evaluate the efficacy and adverse effect of nateglinide in Korean type 2 diabetes patients, whose diabetes were inadequately controlled by medical nutrition therapy, focusing on the changes in mealtime glucose excursion (PBG), fasting blood glucose (FBG), glycated hemoglobin (HbA1c) and plasma insulin. Subjects and Methods: This multicentered open-label trial was conducted on 66 Korean patients with type 2 diabetes mellitus. The subjects comprised of 36 males and 30 females, with a mean age, and duration of diabetes of 53.9±9.6(34~69) years and 39.5±44.0 months, respectively. The inclusion criteria were as follows: 1) FBG and PBG before the trial of 6.7~11.1 m㏖/ℓ and above 11.1 m㏖/ℓ, respectively, 2) changes of FBG and PBG during the 2-week-diet treatment of less than 1.7 m㏖/ℓ. PBG, FGB, HbA1c and plasma insulin levels were measured at weeks -2, 0, 2, 4, 8 and 12. Any adverse effects were noted during the study. The data were analyzed by the intent-to treat (ITT) and the per protocol (PP) methods. Results: Nineteen cases were excluded due to protocol violation or withdrawal. The PBG level was significantly decreased during the study 13.7±2.6 m㏖/ℓ, before the trail to 9.6±2.8 m㏖/ℓ after (p=0.001) which was particularly marked during the first 2 weeks. The FBG, HbA1c and fasting plasma insulin levels were also significantly decreased, from 9.0±1.2 to 8.2±2.0 m㏖/ℓ, p=0.0063), from 8.0±1.3% to 7.0±1.1% (p=0.0001) and from 9.8±7.2 to 8.0±5.5 p㏖/ℓ (p<0.05), respectively. Three adverse events suggested the nateglinide-related diabetes was not serious. Conclusion: This study revealed that nateglinide could be used as an effective glucose-lowering agent, especially for the control of mealtime glucose excursion in Korean type 2 diabetes patients who were inadequately controlled by diet alone.