评估 MBX-102 在二甲双胍血糖控制不佳的 2 型糖尿病患者中的安全性和有效性
一项评估 MBX-102/JNJ-39659100 在二甲双胍单药血糖控制不佳的 2 型糖尿病患者中的安全性和有效性的 2 期多中心、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-102 at daily doses of 400 and 600 mg vs. placebo and Actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day).
研究概览
详细说明
Approximately 240 patients will be randomized in this study, 60 to each of two MBX-102 treatment groups (400 and 600 mg daily), 60 to placebo, and 60 to the Actos® group. Patients in the Actos® group will receive Actos® 30 mg/daily for the first eight weeks of the treatment phase and Actos® 45 mg/daily for the last 16 weeks of the treatment phase. Patients in the MBX-102 400 mg group and MBX-102 600 mg group will continue MBX-102 400 mg and 600 mg, respectively for the full 24 weeks. All study medication will be over-encapsulated; thus, each patient will take two blinded capsules each day containing either placebo, MBX-102 or Actos®. This sample size provides the minimum number expected to ensure a power of at least 90% in detecting a difference of 0.64% in HbA1c between the placebo and experimental treatment, using a two-tailed, two-sample t-test with type 1 error of 0.05, when the pooled standard deviation is ≤ 1.0%, and the discontinuation rate is ≤ 12.5%.
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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Bangalore、印度
- Bangalore Diabetes Centre
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Bangalore、印度
- Diacon Hospital Diabetes & Research Centre
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Bangalore、印度
- M. S. Ramaiah Memorial Hospital
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Bangalore、印度
- St. John's Medical College & Hospital
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Chennai、印度
- Dr. V. Seshiah Diabetes Care & Research Institute
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Hyderabad、印度
- Mediciti Hospital
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Hyderabad、印度
- Medwin Hospital
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Indore、印度
- Diabetes Thyroid Hormone Research Institute Pvt. Ltd.
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Jaipur、印度
- Fortis Hospital
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Karnāl、印度
- Bharti Research Institute of Diabetes & Endocrinology
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Kochi、印度
- Amrita Institute of Medical Sciences
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Mumbai、印度、400067
- Diabetes Action Centre
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Mumbai、印度
- BYL Nair Hospital
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Mumbai、印度
- PD Hindhuja National Hospital
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Nagpur、印度
- Gandhi Endocrinology & Diabetes Centre
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New Delhi、印度
- All India Institute of Medical Sciences
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Pune、印度
- Deenanath Mangeshkar Hospital & Research Centre
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Pune、印度
- Diabetes Care & Research Centre
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Trivendrum、印度
- Health & Research Centre
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Vellore、印度
- Christian Medical College
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Andhra Pradesh
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Hyderabad、Andhra Pradesh、印度、50008
- Kamineni Hospitals Pvt, Ltd.
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California
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Burbank、California、美国、91505
- Providence Clinical Research
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Los Angeles、California、美国、90017
- American Institute of Research
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Nevada
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Las Vegas、Nevada、美国、89101
- Nevada Alliance Against Diabetes
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North Carolina
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Winston-Salem、North Carolina、美国、27103
- Piedmont Medical Research Associates
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Texas
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San Antonio、Texas、美国、78229
- DGD Research, Inc.
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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:
- Patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months
- Male or female, 18-70 years of age
- All female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method. Depo contraceptives are excluded.
- Female patients must not be pregnant or lactating
- BMI ≥ 26 (patients of Asian Indian origin ≥ 22) kg/m2
- HbA1c ≥ 7.5%, ≤ 10.5%
- FPG ≥ 120 mg/dL, ≤ 240 mg/dL
Exclusion Criteria:
- History of diabetes secondary to pancreatitis or pancreatectomy
- Any history of ketoacidosis
- History of insulin use within last one year (insulin use while hospitalized is acceptable)
- Weight loss > 10 pounds in the three months prior to screening visit
- History of TZD use (Actos® or Avandia®) within 6 months of screening visit
- History of TZD discontinuation due to side effect or lack of efficacy
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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greater than or equal to 1500 mg/kg day matching placebo |
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实验性的：MBX-102 400
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capsule greater than or equal to 1500 mg/kg day |
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实验性的：MBX-102 600
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capsule greater than or equal to 1500 mg/kg day |
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有源比较器：Actos
30-45 mg |
greater than or equal to 1500 mg/kg day over-encapsulated to match MBX-102 and placebo |
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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与安慰剂相比，HbA1c 相对于基线的变化
大体时间：24周
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24周
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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与安慰剂相比，空腹血糖 (FPG) 的变化
大体时间：24周
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24周
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合作者和调查者
调查人员
- 首席研究员：Thomas W. Littlejohn, M.D.、Piedmont Medical Research Associates
- 首席研究员：Michael Guice, M.D.、American Institute of Research
- 首席研究员：K. M. Prasanna Kumar, MD、M. S. Ramaiah Memorial Hospital
- 首席研究员：Veerasamy Seshiah, MD、Dr. V. Seshiah Diabetes Care & Research Institute
- 首席研究员：Sanjay Kalra, MD、Bharti Research Institute of Diabetes & Endocrinology
- 首席研究员：Sailesh Lodha, MD、Fortis Hospital
- 首席研究员：Prema Varthakavi, MD、BYL Nair Hospital
- 首席研究员：Sanjiv Shah, MD、Diabetes Action Centre
- 首席研究员：Manoj Chadha, MD、PD Hindhuja National Hospital & Medical Research Centre
- 首席研究员：Mathew Thomas, MD、Health & Research Centre
- 首席研究员：Sanjay Reddy, MD、Bangalore Diabetes Centre
- 首席研究员：Ganapati Bantwal, MD、St Johns Medical College Hospital, Bangalore, India
- 首席研究员：Aravind S Sosale, MD、Diacon Hospital Diabetes & Research Centre
- 首席研究员：Vaishali Deshmukh, MD、Deenanath Mangeshkar Hospital & Research Centre
- 首席研究员：Abhay Mutha, MD、Diabetes Care & Research Centre
- 首席研究员：Nihal Thomas, MD、Christian Medical College, Vellore, India
- 首席研究员：Kirtikumar Modi, MD、Medwin Hospital
- 首席研究员：Sunil Jain, MD、Diabetes Thyroid Hormone Research Institute Pvt. Ltd.
- 首席研究员：Pramod Gandhi, MD、Gandhi Endocrinology & Diabetes Centre
- 首席研究员：Rakesh Kumar Sahay, MD、Mediciti Hospital
- 首席研究员：Harish Kumar, MD、Amrita Institute of Medical Sciences
- 首席研究员：Rubin Savedra, MD、Association of International Professionals, dba Nevada Alliance Against Diabetes
- 首席研究员：Teresa Sligh, MD、Translational Research Group, Inc. dba Providence Clinical Research
- 首席研究员：Prabha Adhikari, MD、Kasturba Medical College Hospital
- 首席研究员：Navneet Agrawal, MD、Diabetes, Obesity and Thyroid Center
- 首席研究员：Swamy Miryala, MD、Kamineni Hospitals Pvt, Ltd.
- 首席研究员：Ariachery C Ammini, MD、All India Institute of Medical Sciences
- 首席研究员：Douglas Denham, M.D.、dgd Research, 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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