Study of the Durability of Glycemic Control With Nateglinide

• Status: Completed
• Trial end date: 2014-06-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajou University School of Medicine
• Collaborators: Bundang CHA Hospital; Hallym University Medical Center; Hanyang University; Inha University Hospital; Korea University Guro Hospital; Kyunghee University Medical Center; Myongji Hospital; Wonju Severance Christian Hospital; Yonsei University
• Treatments: Glimepiride; Nateglinide

Criteria

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