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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Nateglinide 90\~120mg three times a day
Glimepiride 1\~2mg once a day
Hanyang University Medical Center
Guri-si, Gyeonggi-do, South Korea
Myongji Hospital
Ilsan, Kyounggi, South Korea
Inha University Hospital
Incheon, South Korea
Hallym University Medical Center
Seoul, South Korea
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate
% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (\>8.0%)
Time frame: every 3 months following randomization, for 24 months
HbA1c
HbA1c (%) at 24 months
Time frame: at 24 months
Fasting Glucose
fasting glucose (mg/dL) at 24 months
Time frame: at 24 months
C-peptide
c-peptide(uU/mL) at 24 months
Time frame: at 24 months
HOMA-IR
insulin resistance marker HOMA-IR at 24 months
Time frame: at 24 months
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Korea University Guro Hospital
Seoul, South Korea
Kyung hee University Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea