Study of the Durability of Glycemic Control With Nateglinide
NCT ID: NCT00858013
Last Updated: 2017-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
88 participants
INTERVENTIONAL
2009-04-24
2014-06-25
Brief Summary
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Detailed Description
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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 8.0% will be retested 2 weeks later, and if the retested HbA1c is also above 8.0%, those patients will be withdrawn considering monotherapy failure.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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nateglinide
Nateglinide 90\~120mg three times a day
Nateglinide
Nateglinide 90\~120mg three times a day
Glimepiride
Glimepiride 1\~2mg once a day
Glimepiride
Glimepiride 1\~2mg once a day
Interventions
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Nateglinide
Nateglinide 90\~120mg three times a day
Glimepiride
Glimepiride 1\~2mg once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Korea University Guro Hospital
OTHER
Hanyang University
OTHER
Inha University Hospital
OTHER
Kyunghee University Medical Center
OTHER
Myongji Hospital
OTHER
Bundang CHA Hospital
OTHER
Wonju Severance Christian Hospital
OTHER
Hallym University Medical Center
OTHER
Ajou University School of Medicine
OTHER
Responsible Party
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Kwan Woo Lee
Professor
Principal Investigators
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Kwan Woo Lee, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Locations
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Hanyang University Medical Center
Guri-si, Gyeonggi-do, South Korea
Myongji Hospital
Ilsan, Kyounggi, South Korea
Inha University Hospital
Incheon, , South Korea
Hallym University Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyung hee University Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Countries
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Other Identifiers
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AJIRB-CRO-08-197
Identifier Type: -
Identifier Source: org_study_id
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