Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
2014年5月16日 更新者：Boehringer Ingelheim
A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)
This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period.
The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
547
阶段
- 阶段2
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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Chiyoda-ku, Tokyo、日本
- 1245.38.016 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo、日本
- 1245.38.001 Boehringer Ingelheim Investigational Site
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Chuo-ku, Tokyo、日本
- 1245.38.003 Boehringer Ingelheim Investigational Site
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Hachioji, Tokyo、日本
- 1245.38.002 Boehringer Ingelheim Investigational Site
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Hanamaki, Iwate、日本
- 1245.38.010 Boehringer Ingelheim Investigational Site
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Kamakura, Kanagawa、日本
- 1245.38.005 Boehringer Ingelheim Investigational Site
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Kanazawa, Ishikawa、日本
- 1245.38.020 Boehringer Ingelheim Investigational Site
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Kashiwa, Chiba、日本
- 1245.38.013 Boehringer Ingelheim Investigational Site
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Katsushika-ku, Tokyo、日本
- 1245.38.019 Boehringer Ingelheim Investigational Site
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Kyoto, Kyoto、日本
- 1245.38.021 Boehringer Ingelheim Investigational Site
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Matsuyama, Ehime、日本
- 1245.38.024 Boehringer Ingelheim Investigational Site
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Minato-ku, Tokyo、日本
- 1245.38.004 Boehringer Ingelheim Investigational Site
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Moriya, Ibaraki、日本
- 1245.38.011 Boehringer Ingelheim Investigational Site
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Naha, Okinawa、日本
- 1245.38.030 Boehringer Ingelheim Investigational Site
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Okawa, Fukuoka、日本
- 1245.38.032 Boehringer Ingelheim Investigational Site
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Okinawa, Okinawa、日本
- 1245.38.031 Boehringer Ingelheim Investigational Site
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Saga, Saga、日本
- 1245.38.025 Boehringer Ingelheim Investigational Site
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Saitama, Saitama、日本
- 1245.38.014 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido、日本
- 1245.38.006 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido、日本
- 1245.38.007 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido、日本
- 1245.38.008 Boehringer Ingelheim Investigational Site
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Sapporo, Hokkaido、日本
- 1245.38.009 Boehringer Ingelheim Investigational Site
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Sasima-gun, Ibaraki、日本
- 1245.38.012 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo、日本
- 1245.38.015 Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo、日本
- 1245.38.018 Boehringer Ingelheim Investigational Site
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Suginami-ku, Tokyo、日本
- 1245.38.017 Boehringer Ingelheim Investigational Site
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Suita, Osaka、日本
- 1245.38.022 Boehringer Ingelheim Investigational Site
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Ube, Yamaguchi、日本
- 1245.38.023 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa、日本
- 1245.38.026 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa、日本
- 1245.38.027 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa、日本
- 1245.38.028 Boehringer Ingelheim Investigational Site
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Urasoe, Okinawa、日本
- 1245.38.029 Boehringer Ingelheim Investigational Site
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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:
- Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients on diet and exercise regimen who are:
- drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
- pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
HbA1c at Visit 1a:
- for patients who are drug naïve: HbA1c >=7.0 to =<10.0%
- for patients treated with one oral antidiabetic drug: HbA1c >=6.5 to =<9.0%
- HbA1c of >=7.0% and =<10% at Visit 2 (start of run-in)
Exclusion criteria:
- Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
- Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
- Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
- Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
- Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
- Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
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 |
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实验性的：BI 10773 low dose QD
BI 10773 tablets low dose once a day
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每天一次安慰剂药片
Placebo tablets once a day
BI 10773 tablets low dose once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
BI 10773 tablets mid-low dose once a day
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实验性的：BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
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每天一次安慰剂药片
每天一次安慰剂药片
BI 10773 tablets low dose once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
BI 10773 tablets mid-low dose once a day
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实验性的：BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
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每天一次安慰剂药片
每天一次安慰剂药片
Placebo tablets once a day
BI 10773 tablets low dose once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
BI 10773 tablets mid-low dose once a day
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实验性的：BI 10773 high dose QD
BI 10773 tablets high dose once a day
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每天一次安慰剂药片
Placebo tablets once a day
BI 10773 tablets low dose once a day
BI 10773 tablets mid-high dose once a day
BI 10773 tablets high dose once a day
BI 10773 tablets mid-low dose once a day
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安慰剂比较：Placebo
Placebo tablets once a day
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每天一次安慰剂药片
每天一次安慰剂药片
Placebo tablets once a day
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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 |
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Change From Baseline in HbA1c After 12 Weeks of Treatment.
大体时间：baseline and 12 weeks
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The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
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baseline and 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Occurrence of Treat to Target Efficacy Response
大体时间：baseline and 12 weeks
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Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment
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baseline and 12 weeks
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Change From Baseline in FPG
大体时间：baseline and 12 weeks
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Change from baseline in FPG after 12 weeks of treatment
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baseline and 12 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Confirmed Hypoglycaemic Adverse Events
大体时间：between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
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Number of patients with confirmed hypoglycaemic adverse events
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between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
- Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
- Kadowaki T, Haneda M, Inagaki N, Terauchi Y, Taniguchi A, Koiwai K, Rattunde H, Woerle HJ, Broedl UC. Efficacy and safety of empagliflozin monotherapy for 52 weeks in Japanese patients with type 2 diabetes: a randomized, double-blind, parallel-group study. Adv Ther. 2015 Apr;32(4):306-18. doi: 10.1007/s12325-015-0198-0. Epub 2015 Apr 7.
有用的网址
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
2010年9月1日
初级完成 (实际的)
2012年6月1日
研究完成 (实际的)
2012年6月1日
研究注册日期
首次提交
2010年8月31日
首先提交符合 QC 标准的
2010年8月31日
首次发布 (估计)
2010年9月1日
研究记录更新
最后更新发布 (估计)
2014年6月17日
上次提交的符合 QC 标准的更新
2014年5月16日
最后验证
2014年5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.