Status:
COMPLETED
Study of the Durability of Glycemic Control With Nateglinide
Lead Sponsor:
Ajou University School of Medicine
Collaborating Sponsors:
Korea University Guro Hospital
Hanyang University
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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) wi...
Eligibility Criteria
Inclusion
- 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)
- 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
- 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
Key Trial Info
Start Date :
April 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2014
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00858013
Start Date
April 24 2009
End Date
June 25 2014
Last Update
May 16 2017
Active Locations (7)
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1
Hanyang University Medical Center
Guri-si, Gyeonggi-do, South Korea
2
Myongji Hospital
Ilsan, Kyounggi, South Korea
3
Inha University Hospital
Incheon, South Korea
4
Hallym University Medical Center
Seoul, South Korea