Study of the Durability of Glycemic Control With Nateglinide

Phase 4

Completed

Brief Summary: This multi-center, randomized controlled study aims to evaluate the durability and efficacy of nateglinide therapy for long term glycemic control compared with glimepiride.

Detailed Description: 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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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.

Recruitment & Eligibility

Inclusion Criteria

type 2 diabetes mellitus
age>=18years
no anti hyperglycemic agent for 3 months or low-dose oral hypoglycemic therapy
- metformin≤1g/day, acarbose≤300mg/day, voglibose≤0.9mg/day, nateglinide≤270mg/day, gliclazide≤80mg/day, glimepiride≤2mg/day, glibenclamide≤5mg/day (nateglinide or sulfonylurea <6months)
6.5% ≤ HbA1c ≤ 8.5%
- patients on no anti hyperglycemic agent for 3 months : HbA1c at screening
- patients on oral hypoglycemic therapy in 3months : HbA1c after wash-out

Exclusion Criteria

attending other clinical trials in 3months
type I diabetes mellitus
taking systemic steroid in 1month or requiring steroid therapy during clinical trial
acute myocardial infarction in 6months
alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
severe liver disease or AST, ALT ≥ 2.5 x ULN
renal insufficiency (serum creatinine > 2.0mg/dl)
other severe diabetic complication
drug hypersensitivity history to nateglinide or sulfonylurea
pregnant or plan to become pregnant during the clinical trial, lactation

Arm && Interventions

Group	Intervention	Description
Nateglinide	Nateglinide	Nateglinide 90\~120mg three times a day
Glimepiride	Glimepiride	Glimepiride 1\~2mg once a day

Primary Outcome Measures

Name	Time	Method
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate	every 3 months following randomization, for 24 months	% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (\>8.0%)

Secondary Outcome Measures

Name	Time	Method
HbA1c	at 24 months	HbA1c (%) at 24 months
Fasting Glucose	at 24 months	fasting glucose (mg/dL) at 24 months
HOMA-IR	at 24 months	insulin resistance marker HOMA-IR at 24 months
C-peptide	at 24 months	c-peptide(uU/mL) at 24 months

Locations (7): Korea University Guro Hospital
🇰🇷
Seoul, Korea, Republic of
Kyung hee University Medical Center
🇰🇷
Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷
Guri-si, Kyunggi-do, Korea, Republic of
Inha University Hospital
🇰🇷
Incheon, Korea, Republic of
Ajou University Hospital
🇰🇷
Suwon-si, Korea, Republic of
Hallym University Medical Center
🇰🇷
Seoul, Korea, Republic of
Myongji Hospital
🇰🇷
Ilsan, Kyounggi, Korea, Republic of