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临床试验/KCT0000052
KCT0000052招募中未知

Multi-center, Randomized, Open label Study of the Durability of glycemic control with Nateglinide versus Glimepiride as monotherapy in type 2 diabetic patients

Ajou University Hospital0 个研究点目标入组 200 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional Study

入排标准

年龄范围
18(Year) 至 o Limit(—)
性别
All

入选标准

  • ‣ 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

排除标准

  • ‣ 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

研究者

发起方
Ajou University Hospital

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