Study of the Durability of Glycemic Control With Nateglinide
Information source: Ajou University School of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Nateglinide (Drug); Glimepiride (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Ajou University School of Medicine Official(s) and/or principal investigator(s):
Kwan Woo Lee, MD,PhD, Principal Investigator, Affiliation: Ajou University Hospital
Overall contact:
Kwan Woo Lee, MD, PhD, Phone: 82-31-219-4526, Email: lkw65@ajou.ac.kr
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.
Clinical Details
Official title: Multi-Center, Randomized, Open Label Study of the Durability of Glycemic Control With Nateglinide Versus Glimepiride as Monotherapy in Type 2 Diabetic Patients
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: The durability of nateglinide in comparison with those of glimepiride based on the withdrawal rate
Secondary outcome: 1. HbA1c, Fasting blood sugar, 2hours postprandial blood sugar
2. insulin secretion(C-peptide), insulin sensitivity(HOMA-IR), lipid profile
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retested HbA1c is also above 8. 0%, those patients will be withdrawn considering monotherapy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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Kwan Woo Lee, MD, PhD, Phone: 82-31-219-4526, Email: lkw65@ajou.ac.kr
Ajou University Hospital, Suwon, Korea, Republic of
Kyung hee University Medical Center, Seoul, Korea, Republic of
Korea University Guro Hospital, Seoul, Korea, Republic of
Inha University Hospital, In Cheon, Korea, Republic of
Hanyang University Medical Center, Kuri, Kyunggi-do, Korea, Republic of
Additional Information
Starting date: April 2009
Ending date: December 2012
Last updated: March 6, 2009
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