Type 2 Diabetes Mellitus Clinical Trial
Official title:
Multi-center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients
This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.
Selected patients will be randomly assigned to receive nateglinide or glimepiride.
Previous treatment with oral antidiabetic drugs (metformin, a-glucosidase inhibitor,
nateglinide or sulfonylurea) will be discontinued. After a 1 month wash-out period (if 6.5 ≤
HbA1c ≤ 8.5), patients will take randomly assigned drugs for 24 months.
Patients will be met by the trial investigator every 3 months following randomization. At
each visit, patients whose HbA1c is > 8.0% will be retested 2 weeks later, and if the
retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy
failure. We will evaluate the durability of nateglinide in comparison with that of
glimepiride based on the withdrawal rate.
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