Study of the Durability of Glycemic Control With Nateglinide

Ajou University School of Medicine

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Nateglinide

Drug: Glimepiride

Study type

Interventional

Funder types

Other

Identifiers

NCT00858013

AJIRB-CRO-08-197

Details and patient eligibility

About

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

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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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