此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes

2012年5月17日 更新者：LG Life Sciences

A Multicenter, Multinational, Randomized, Active-controlled, Parallel Group, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of LC15-0444 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone

Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group study The study was divided into three parts: part 1 was a screening period started with an initial 2 weeks of exercise/diet program; part 2 was a double-blind treatment period during which eligible patients were randomized to Sitagliptin 100 mg qd (once daily), LC15-0444 25 mg bid (twice daily), or LC15-0444 50 mg qd groups and received the assigned treatment for 24 weeks; part 3 was for those patients who completed part 1 & 2 and consented to receive another 28 weeks of treatment with LC15-0444 50 mg qd.

Screening tests were performed on the patients who had given the written informed consent. After 2-week exercise/diet program according to the generally recognized guideline, eligible patients were assigned one of three treatment groups with 1:1:1 ratio. During the total of 24-week treatment period of part 2, each patient visited the study site at Week 6, 12, 18, and 24. Completing double-blind treatment for 24 weeks, each patient was asked to provide consent to participate in the part 3 of the study where all the patients were to receive LC15-0444 50 mg once daily. During 28-week treatment period of the part 3, each patient visited the study

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

425

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 大韩民国
      • Seoul、大韩民国、110-062
        • LG Life Sciences

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patients with Type 2 Diabetes Mellitus
  2. Adults between 18 and 75 years of age
  3. Patients with HbA1c between 7% and 11%
  4. Patients treated with metformin monotherapy for at least 12 weeks and treated with 1000 mg/day or higher dose of metformin for at least 4 weeks right before screening
  5. Patients who signed on the consent form after informed on the object, method, and risks of the clinical study

Exclusion Criteria:

  1. Patients with type 1 diabetes mellitus, gestational diabetes, or secondary diabetes
  2. Patients who were taking or needed to take any drugs which may affect the control of blood glucose significantly (ex. glucocorticoids)
  3. Patients who had experienced myocardial infarction, unstable angina or prior history of coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment
  4. Patients with NYHA class II-IV congestive heart failure
  5. Patients with history of hepatic cirrhosis
  6. Patients with renal failure or whose creatinine clearance was less than 60 ml/min
  7. Patients with dysfunctional thyroid gland (with abnormal level of TSH)
  8. Patients with ALT, AST or CPK exceeding 2.5 times of the upper limit of the normal range
  9. Patients with BMI below 20 kg/m2 or exceeding 40 kg/m2
  10. Patients with history of asthma or major skin allergy
  11. Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.
  12. Patients with history of hypersensitivity to metformin or biguanides.
  13. Patients with history of hypersensitivity to thiazolidinediones
  14. Patients who took sodium channel blockers in the last 6 weeks prior to Visit 1.
  15. Patients who were treated with insulin or glucagon-like peptide-1 (GLP-1) analogue or who took thiazolidinediones (Glitazone) in the last 6 months prior to Visit 1.
  16. Patients with other reasons who the investigator decided not to be eligible for the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：LC15-0444 25 mg bid
LC15-0444 25 mg bid(twice daily)added on Metformin therapy
药品：LC15-0444 25mg bid
Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
实验性的：LC15-0444 50 mg qd
LC15-0444 50 mg qd(once daily) added on Metformin therapy
药品：LC15-0444 50mg qd
Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
有源比较器：Sitagliptin 100mg qd
Sitagliptin 100 mg qd (once daily) added on the Metformin therapy
药品：Sitagliptin 100mg qd
Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
HbAlc 的变化
大体时间：从基线到第 24 周
从基线到第 24 周

次要结果测量

结果测量
措施说明
大体时间
HbA1c Responder Rate
大体时间：at Week 24
responder rate of HbA1c <7%, <6.5% at week 24
at Week 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

LG Life Sciences

调查人员

  • 首席研究员：Sun Woo Kim, MD, PhD、Kangbuk Samsung Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年12月1日

初级完成 (实际的)

2011年6月1日

研究完成 (实际的)

2012年5月1日

研究注册日期

首次提交

2012年5月15日

首先提交符合 QC 标准的

2012年5月17日

首次发布 (估计)

2012年5月18日

研究记录更新

最后更新发布 (估计)

2012年5月18日

上次提交的符合 QC 标准的更新

2012年5月17日

最后验证

2012年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LG-DPCL006

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅