Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea (JAS)
2012年9月9日 更新者：Sung-Chen Liu
Efficacy of Adding Sitagliptin or Pioglitazone to Patients With Type 2 Diabetes Insufficiently Controlled With Metformin and Sulfonylurea
This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.
研究概览
详细说明
This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria: type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks. > 20 years old; A1C:> 7.0 % and < 11% Exclusion criteria: insulin use within 12 weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) > 2.5 times the upper limit of normal (ULN), current or prepare to pregnancy and lactation.
Primary Purpose:
compare the change in hemoglobin A1c and the proportion of patients achieving A1C < 7% between the 2 groups
Secondary Purposes:
- Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP)
- Homeostasis model assessment-β cell function(HOMA-β) will be calculated to assess changes in β-cell function and HOMA-insulin resistance(HOMA-IR)to assess changes in insulin resistance
- Body weight change, proportion of side effects
研究类型
介入性
注册 (实际的)
120
阶段
- 第四阶段
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
-
-
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Taipei、台湾、10449
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
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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
20年 至 80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:
- Type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks
- > 20 years old
- A1C: > 7.0 % and < 11%
Exclusion Criteria:
- Insulin use within 12 weeks of the screening visit
- Any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase levels > 2.5 times the upper limit of normal
- Current or prepare to pregnancy and lactation
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：sitagliptin
add sitagliptin100mg/d to pre-study OADs
|
add sitagliptin100mg/d to pre-study OADs
其他名称：
|
|
有源比较器：pioglitazone
add pioglitazone 30mg/d to pre-study OADs
|
add pioglitazone 30mg/d to pre-study OADs
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Change in Glycosylated Hemoglobin (A1C)
大体时间：24 weeks
|
A1C change from baseline to 24 weeks
|
24 weeks
|
|
Baseline A1C
大体时间：Baseline
|
baseline A1C
|
Baseline
|
|
The Percentages of Patient Achieving an A1C <7%
大体时间：24 weeks
|
The percentages of patient achieving an A1C <7% at endpoint
|
24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Fasting Plasma Glucose
大体时间：24 weeks
|
fasting serum sugar change from baseline to 24 weeks
|
24 weeks
|
|
Changes in High Sensitive C-reactive Protein
大体时间：24 weeks
|
fasting high sensitive serum C-reactive protein change from baseline to 24 weeks
|
24 weeks
|
|
Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
大体时间：24 weeks
|
HOMA-IR change from baseline to 24 weeks
|
24 weeks
|
|
Body Weight Change
大体时间：24 weeks
|
body weight change from baseline to 24 weeks
|
24 weeks
|
|
Percentages of Patients With Total Adverse Events (AE)
大体时间：24 weeks
|
percentages of total adverse events
|
24 weeks
|
|
Change in Fasting Total-cholesterol
大体时间：24 weeks
|
Total-cholesterol change from baseline to 24 weeks
|
24 weeks
|
|
Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
大体时间：24 weeks
|
LDL-C change from baseline to 24 weeks
|
24 weeks
|
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Change in Fasting Triglycerides(TG)
大体时间：24 weeks
|
TG change from baseline to 24 weeks
|
24 weeks
|
|
Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)
大体时间：24 weeks
|
HDL-C change from baseline to 24 weeks
|
24 weeks
|
|
Change in Fasting Plasma Alanine-aminotransferase (ALT)
大体时间：24 weeks
|
ALT change from baseline to 24 weeks
|
24 weeks
|
|
Percentages of Patients With Mild to Moderate Hypoglycemia
大体时间：24 weeks
|
Incidence of mild to moderate hypoglycemia after treatment
|
24 weeks
|
|
Percentages of Patients With Edema
大体时间：24 weeks
|
proportion of edema after treatment
|
24 weeks
|
|
Percentages of Patients With Gastrointestinal Adverse Events
大体时间：24 weeks
|
Proportion of Gastrointestinal adverse events after treatment
|
24 weeks
|
|
Percentages of Patients With Nasopharyngitis
大体时间：24 weeks
|
Proportion of Nasopharyngitis after treatment
|
24 weeks
|
|
Percentages of Patients With Severe Hypoglycemia
大体时间：24 weeks
|
Proportion of severe hypoglycemia after treatment
|
24 weeks
|
|
Baseline Fasting Plasma Glucose
大体时间：baseline
|
Baseline fasting plasma glucose
|
baseline
|
|
Baseline High Sensitive C-reactive Protein
大体时间：baseline
|
Baseline high sensitive C-reactive Protein
|
baseline
|
|
Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
大体时间：Baseline HOMA-IR
|
Baseline HOMA-IR
|
Baseline HOMA-IR
|
|
Baseline Alanine-aminotransferase (ALT)
大体时间：Baseline
|
Baseline alanine-aminotransferase
|
Baseline
|
|
Baseline Body Weight
大体时间：Baseline
|
Baseline body weight
|
Baseline
|
|
Baseline Total Cholesterol
大体时间：Baseline
|
Baseline Total cholesterol
|
Baseline
|
|
Baseline Triglyceride (TG)
大体时间：Baseline
|
Baseline TG
|
Baseline
|
|
Baseline Low-density Lipoprotein Cholesterol (LDL-C)
大体时间：Baseline
|
Baseline LDL-C
|
Baseline
|
|
Baseline High-density Lipoprotein Cholesterol (HDL-C)
大体时间：Baseline
|
Baseline HDL-C
|
Baseline
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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。
调查人员
- 首席研究员：Sung-Chen Liu, MD、Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial 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10月1日
初级完成 (实际的)
2011年10月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2010年9月2日
首先提交符合 QC 标准的
2010年9月2日
首次发布 (估计)
2010年9月3日
研究记录更新
最后更新发布 (估计)
2012年10月10日
上次提交的符合 QC 标准的更新
2012年9月9日
最后验证
2012年9月1日
更多信息
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.