The evaluation of the durability and efficacy of nateglinide therapy fro long term glycemic control compared with glimepiride in type 2 diabetic patients
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000052
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
‣ Type 2 diabetes mellitus
‣ Age >=18 years
‣ 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
‣ 6.5% <_ HbA1c <_8.5%
‣ patients on no anti hyperglycemic agent for 3 months: HbA1c at screening
‣ patients on oral hypoglycemic therapy in 3 months: HbA1c after wash-out
‣ attending other clinical trails in 3 months
‣ type 1 diabetes mellitus
‣ taking systemic steroid in 1months or requiring steroid therapy during clincal trial
‣ acute myocaldial infacrtion in 6 months
‣ alcoholics, pituitary or adrenal insufficiency, severe ketosis, diabetic ketoacidosis
‣ severe liver disease or AST, ALT >_ 2,5 * ULM
‣ renal insufficiency (serum creatinine > 2.0 mg/dl)
‣ other severe diabetic complication
‣ drug hypersensitivity history to nateglinide or sulfonylurea
‣ pregnant or plan to becom pregnant during the cliniclatrial, lactation
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Durability
- Secondary Outcome Measures
Name Time Method serum glucose (HbA1C, fasting blood glucose, 2-hour postprandial blood glucose);insulin secrestion (C-peptide);insulin sensitivity (HOMA-IR);lipid profile (TC, TG, LDL, HDL);hypoglycemic event;body weight and waist circumference