评估 MBX-2982 每日给药 4 周作为 2 型糖尿病患者单一疗法的疗效、安全性、耐受性和药代动力学的研究
评估 MBX-2982 作为 2 型糖尿病患者单药治疗 4 周的疗效、安全性、耐受性和药代动力学的第 2 期随机、双盲、安慰剂和活性比较剂对照研究
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).
研究概览
详细说明
Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Tbilisi、乔治亚州、0144
- Healthy Life Clinical Diagnostic Center
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Tbilisi、乔治亚州、0159
- Georgian Diabetes Center
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Tbilisi、乔治亚州、0186
- Medulla Chemotherapy and Immunotherapy Clinic
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Bangalore、印度、560 054
- Gokula Metropolis Research, MS Ramaiah Memorial Hospital
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Bangalore、印度、560043
- Medisys Clinisearch India Pvt Ltd
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Ghaziabad、印度、201002
- Hormone Care Research Centre
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Malleshwaram、印度、560 003
- Bangalore Endocrinology & Diabetes Research Centre
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Haryana
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Karnāl、Haryana、印度、132001
- Bharti Research Institute of Diabetes and Endocrinology
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M.P.
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Indore、M.P.、印度、452001
- Diabetes Thyroid Hormone Research Institute Pvt Ltd
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Nagpur
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Rāmdaspeth、Nagpur、印度、10
- Gandhi Endocrinology & Diabetes Centre
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California
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Los Angeles、California、美国、90036
- Impact Clinical Trials
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Nevada
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Las Vegas、Nevada、美国、89101
- Nevada Alliance Against Diabetes
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New York
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Binghamton、New York、美国、13901
- United Medical Associates
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Texas
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San Antonio、Texas、美国、78229
- dgd Research, Inc., a Cetero Research Co.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- History of type 2 diabetes of at least 3 months duration
- Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone)
- HbA1c 7.0-8.5% (inclusive) at screening
- BMI ≥ 26 kg/m2 for patients recruited from U.S or Georgia or ≥ 22 kg/m2 for patients recruited from India
Exclusion Criteria:
- Any history of type 1 diabetes or diabetic ketoacidosis
- History of major upper GI surgery
- Evidence or history of clinically significant GI illness including dyspepsia, PUD, nausea, diarrhea, malabsorption, etc.
- History of outpatient insulin use within last 1 year (insulin use while hospitalized is acceptable)
- Weight loss > 10 pounds (4.5 kg) in the 3 months prior to screening visit or use of weight loss medications (prescription or OTC) within 30 days of screening
学习计划
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：安慰剂
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tablets and capsule once daily |
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实验性的：MBX-2982 25 毫克
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tablets and capsule once daily |
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实验性的：MBX-2982 100 毫克
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tablets and capsule once daily |
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实验性的：MBX-2982 300 毫克
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tablets and capsule once daily |
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有源比较器：西格列汀 100 毫克
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tablets and capsule once daily |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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评估 MBX-2982 对与标准化早餐和午餐相关的 14 点血糖水平的平均加权平均值相对于基线和安慰剂的绝对变化和百分比变化的影响
大体时间：4周
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4周
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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评估 MBX-2982 对其他血糖参数的影响。
大体时间：4周
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4周
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合作者和调查者
调查人员
- 研究主任：Brian Roberts, MD、Metabolex, Inc.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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