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Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

2014年5月16日 更新者：Boehringer Ingelheim

A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 10773 and Sitagliptin Administered Orally Over 24 Weeks, in Drug naïve Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Diet and Exercise

The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

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)

986

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

  • 中国
      • Beijing、中国
        • 1245.20.86007 Boehringer Ingelheim Investigational Site
      • Beijing、中国
        • 1245.20.86008 Boehringer Ingelheim Investigational Site
      • Guangzhou、中国
        • 1245.20.86001 Boehringer Ingelheim Investigational Site
      • Guangzhou、中国
        • 1245.20.86002 Boehringer Ingelheim Investigational Site
      • Guangzhou、中国
        • 1245.20.86003 Boehringer Ingelheim Investigational Site
      • Guiyang、中国
        • 1245.20.86012 Boehringer Ingelheim Investigational Site
      • Hangzhou、中国
        • 1245.20.86020 Boehringer Ingelheim Investigational Site
      • Jinan、中国
        • 1245.20.86049 Boehringer Ingelheim Investigational Site
      • Jingzhou、中国
        • 1245.20.86018 Boehringer Ingelheim Investigational Site
      • Nanchang、中国
        • 1245.20.86019 Boehringer Ingelheim Investigational Site
      • Nanjing、中国
        • 1245.20.86010 Boehringer Ingelheim Investigational Site
      • Nanjing、中国
        • 1245.20.86043 Boehringer Ingelheim Investigational Site
      • QingDao、中国
        • 1245.20.86016 Boehringer Ingelheim Investigational Site
      • Shanghai、中国
        • 1245.20.86004 Boehringer Ingelheim Investigational Site
      • Shanghai、中国
        • 1245.20.86005 Boehringer Ingelheim Investigational Site
      • Shanghai、中国
        • 1245.20.86006 Boehringer Ingelheim Investigational Site
      • Shenyang、中国
        • 1245.20.86057 Boehringer Ingelheim Investigational Site
      • Shiyan、中国
        • 1245.20.86017 Boehringer Ingelheim Investigational Site
      • Suzhou、中国
        • 1245.20.86013 Boehringer Ingelheim Investigational Site
      • Taiyuan、中国
        • 1245.20.86015 Boehringer Ingelheim Investigational Site
      • Wuhan、中国
        • 1245.20.86009 Boehringer Ingelheim Investigational Site
      • Xi'An、中国
        • 1245.20.86011 Boehringer Ingelheim Investigational Site
      • Xiamen、中国
        • 1245.20.86014 Boehringer Ingelheim Investigational Site
  • 加拿大
    • British Columbia
      • Chilliwack、British Columbia、加拿大
        • 1245.20.20011 Boehringer Ingelheim Investigational Site
      • Victoria、British Columbia、加拿大
        • 1245.20.20018 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg、Manitoba、加拿大
        • 1245.20.20015 Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Moncton、New Brunswick、加拿大
        • 1245.20.20012 Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl、Newfoundland and Labrador、加拿大
        • 1245.20.20016 Boehringer Ingelheim Investigational Site
      • St. John's、Newfoundland and Labrador、加拿大
        • 1245.20.20008 Boehringer Ingelheim Investigational Site
    • Ontario
      • Barrie、Ontario、加拿大
        • 1245.20.20001 Boehringer Ingelheim Investigational Site
      • Hamilton、Ontario、加拿大
        • 1245.20.20019 Boehringer Ingelheim Investigational Site
      • London、Ontario、加拿大
        • 1245.20.20010 Boehringer Ingelheim Investigational Site
      • London、Ontario、加拿大
        • 1245.20.20017 Boehringer Ingelheim Investigational Site
      • Markham、Ontario、加拿大
        • 1245.20.20003 Boehringer Ingelheim Investigational Site
      • Newmarket、Ontario、加拿大
        • 1245.20.20009 Boehringer Ingelheim Investigational Site
      • Ottawa、Ontario、加拿大
        • 1245.20.20013 Boehringer Ingelheim Investigational Site
      • Strathroy、Ontario、加拿大
        • 1245.20.20005 Boehringer Ingelheim Investigational Site
      • Toronto、Ontario、加拿大
        • 1245.20.20002 Boehringer Ingelheim Investigational Site
      • Toronto、Ontario、加拿大
        • 1245.20.20006 Boehringer Ingelheim Investigational Site
    • Prince Edward Island
      • Charlottetown、Prince Edward Island、加拿大
        • 1245.20.20014 Boehringer Ingelheim Investigational Site
      • Montague、Prince Edward Island、加拿大
        • 1245.20.20007 Boehringer Ingelheim Investigational Site
    • Quebec
      • Trois Rivieres、Quebec、加拿大
        • 1245.20.20021 Boehringer Ingelheim Investigational Site
  • 印度
      • Bangalore、印度
        • 1245.20.91005 Boehringer Ingelheim Investigational Site
      • Bangalore、印度
        • 1245.20.91006 Boehringer Ingelheim Investigational Site
      • Bangalore、印度
        • 1245.20.91008 Boehringer Ingelheim Investigational Site
      • Belgaum、印度
        • 1245.20.91003 Boehringer Ingelheim Investigational Site
      • Chennai、印度
        • 1245.20.91004 Boehringer Ingelheim Investigational Site
      • Chennai、印度
        • 1245.20.91009 Boehringer Ingelheim Investigational Site
      • Mumbai、印度
        • 1245.20.91002 Boehringer Ingelheim Investigational Site
      • Mumbai, Maharastra、印度
        • 1245.20.91007 Boehringer Ingelheim Investigational Site
      • Nagpur、印度
        • 1245.20.91010 Boehringer Ingelheim Investigational Site
      • Tamil Nadu、印度
        • 1245.20.91001 Boehringer Ingelheim Investigational Site
  • 德国
      • Dresden、德国
        • 1245.20.49013 Boehringer Ingelheim Investigational Site
      • Düsseldorf、德国
        • 1245.20.49016 Boehringer Ingelheim Investigational Site
      • Frankfurt、德国
        • 1245.20.49015 Boehringer Ingelheim Investigational Site
      • Haag、德国
        • 1245.20.49019 Boehringer Ingelheim Investigational Site
      • Hohenmölsen、德国
        • 1245.20.49020 Boehringer Ingelheim Investigational Site
      • Köthen、德国
        • 1245.20.49014 Boehringer Ingelheim Investigational Site
      • Neuwied、德国
        • 1245.20.49002 Boehringer Ingelheim Investigational Site
      • Nürnberg、德国
        • 1245.20.49008 Boehringer Ingelheim Investigational Site
      • Schauenburg、德国
        • 1245.20.49022 Boehringer Ingelheim Investigational Site
      • St. Ingbert/Oberwürzbach、德国
        • 1245.20.49017 Boehringer Ingelheim Investigational Site
      • Unterschneidheim、德国
        • 1245.20.49003 Boehringer Ingelheim Investigational Site
  • 日本
      • Chiyoda-ku, Tokyo、日本
        • 1245.20.81007 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo、日本
        • 1245.20.81001 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo、日本
        • 1245.20.81002 Boehringer Ingelheim Investigational Site
      • Ebetsu, Hokkaido、日本
        • 1245.20.81005 Boehringer Ingelheim Investigational Site
      • Kamakura, Kanagawa、日本
        • 1245.20.81004 Boehringer Ingelheim Investigational Site
      • Minato-ku, Tokyo、日本
        • 1245.20.81003 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo、日本
        • 1245.20.81006 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo、日本
        • 1245.20.81008 Boehringer Ingelheim Investigational Site
      • Suita, Osaka、日本
        • 1245.20.81009 Boehringer Ingelheim Investigational Site
      • Ube, Yamaguchi、日本
        • 1245.20.81010 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa、日本
        • 1245.20.81012 Boehringer Ingelheim Investigational Site
      • Urasoe, Okinawa、日本
        • 1245.20.81013 Boehringer Ingelheim Investigational Site
  • 比利时
      • Bruxelles、比利时
        • 1245.20.32008 Boehringer Ingelheim Investigational Site
      • Bruxelles、比利时
        • 1245.20.32011 Boehringer Ingelheim Investigational Site
      • Bruxelles、比利时
        • 1245.20.32023 Boehringer Ingelheim Investigational Site
      • De Pinte、比利时
        • 1245.20.32003 Boehringer Ingelheim Investigational Site
      • Deurne、比利时
        • 1245.20.32015 Boehringer Ingelheim Investigational Site
      • Deurne、比利时
        • 1245.20.32016 Boehringer Ingelheim Investigational Site
      • Gozée、比利时
        • 1245.20.32025 Boehringer Ingelheim Investigational Site
      • Landen、比利时
        • 1245.20.32022 Boehringer Ingelheim Investigational Site
      • Leopoldsburg、比利时
        • 1245.20.32019 Boehringer Ingelheim Investigational Site
      • Linkebeek、比利时
        • 1245.20.32024 Boehringer Ingelheim Investigational Site
      • Mouscron、比利时
        • 1245.20.32021 Boehringer Ingelheim Investigational Site
      • Retie、比利时
        • 1245.20.32027 Boehringer Ingelheim Investigational Site
      • Sint-Gillis-Waas、比利时
        • 1245.20.32020 Boehringer Ingelheim Investigational Site
      • Tielt、比利时
        • 1245.20.32018 Boehringer Ingelheim Investigational Site
      • Tremelo、比利时
        • 1245.20.32026 Boehringer Ingelheim Investigational Site
  • 爱尔兰
      • Co. Cork、爱尔兰
        • 1245.20.35302 Boehringer Ingelheim Investigational Site
      • Co. Galway、爱尔兰
        • 1245.20.35305 Boehringer Ingelheim Investigational Site
      • Co. Wexford、爱尔兰
        • 1245.20.35303 Boehringer Ingelheim Investigational Site
      • Offaly、爱尔兰
        • 1245.20.35304 Boehringer Ingelheim Investigational Site
      • Wexford、爱尔兰
        • 1245.20.35306 Boehringer Ingelheim Investigational Site
  • 瑞士
      • Lugano、瑞士
        • 1245.20.41004 Boehringer Ingelheim Investigational Site
      • Rorschach、瑞士
        • 1245.20.41003 Boehringer Ingelheim Investigational Site
  • 美国
    • Arizona
      • Mesa、Arizona、美国
        • 1245.20.10124 Boehringer Ingelheim Investigational Site
      • Phoenix、Arizona、美国
        • 1245.20.10108 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Hot Springs、Arkansas、美国
        • 1245.20.10150 Boehringer Ingelheim Investigational Site
    • California
      • Chino、California、美国
        • 1245.20.10154 Boehringer Ingelheim Investigational Site
      • Santa Ana、California、美国
        • 1245.20.10009 Boehringer Ingelheim Investigational Site
      • West Hills、California、美国
        • 1245.20.10131 Boehringer Ingelheim Investigational Site
    • Colorado
      • Northglenn、Colorado、美国
        • 1245.20.10038 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater、Florida、美国
        • 1245.20.10137 Boehringer Ingelheim Investigational Site
      • Miami、Florida、美国
        • 1245.20.10006 Boehringer Ingelheim Investigational Site
      • Plantation、Florida、美国
        • 1245.20.10085 Boehringer Ingelheim Investigational Site
      • Tampa、Florida、美国
        • 1245.20.10078 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur、Georgia、美国
        • 1245.20.10080 Boehringer Ingelheim Investigational Site
    • Indiana
      • Avon、Indiana、美国
        • 1245.20.10128 Boehringer Ingelheim Investigational Site
      • Fishers、Indiana、美国
        • 1245.20.10060 Boehringer Ingelheim Investigational Site
      • Indianapolis、Indiana、美国
        • 1245.20.10065 Boehringer Ingelheim Investigational Site
    • Kansas
      • Arkansas City、Kansas、美国
        • 1245.20.10117 Boehringer Ingelheim Investigational Site
      • Wichita、Kansas、美国
        • 1245.20.10039 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Louisville、Kentucky、美国
        • 1245.20.10146 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Watertown、Massachusetts、美国
        • 1245.20.10144 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Brick、New Jersey、美国
        • 1245.20.10115 Boehringer Ingelheim Investigational Site
    • Ohio
      • Carlisle、Ohio、美国
        • 1245.20.10129 Boehringer Ingelheim Investigational Site
      • Cincinnati、Ohio、美国
        • 1245.20.10045 Boehringer Ingelheim Investigational Site
      • Cincinnati、Ohio、美国
        • 1245.20.10119 Boehringer Ingelheim Investigational Site
      • Gallipolis、Ohio、美国
        • 1245.20.10130 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston、Texas、美国
        • 1245.20.10089 Boehringer Ingelheim Investigational Site
      • Hurst、Texas、美国
        • 1245.20.10151 Boehringer Ingelheim Investigational Site
      • San Antonio、Texas、美国
        • 1245.20.10155 Boehringer Ingelheim Investigational Site

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 及以上 (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. Diagnosis of type 2 diabetes mellitus prior to informed consent;
  2. Male and female patients on diet and exercise regimen who are drug-naïve;
  3. HbA1c >= 7.0% and <= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c > 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
  4. Age >= 20 (Japan); Age >= 18 (countries other than Japan);
  5. BMI <= 45 kg/m2 at Visit 1 (screening);
  6. Signed and dated written informed consent by date of Visit 1

Exclusion criteria:

  1. Uncontrolled hyperglycaemia;
  2. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
  3. Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
  4. Impaired renal function (eGFR<50 ml/min);
  5. Bariatric surgery within the past two years or other GI surgeries;
  6. Medical history of cancer;
  7. Contraindications to sitagliptin;
  8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
  9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
  10. Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
  11. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
  12. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
  13. Alcohol or drug abuse;
  14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
  15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial

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：BI 10773 low dose
Patients receive BI 10773 low dose tablets once daily
药品：BI 10773
BI 10773 低剂量片剂，每日一次
药品：Placebo identical to BI10773 high dose
placebo tablets once daily
药品：Placebo identical to Sitagliptin 100mg
placebo tablets once daily
实验性的：BI 10773 high dose
Patients receive BI 10773 high dose tablets once daily
药品：Placebo identical to Sitagliptin 100mg
placebo tablets once daily
药品：Placebo identical to BI10773 low dose
placebo tablets once daily
药品：BI10773
BI 10773 high dose tablets once daily
安慰剂比较：Placebo
Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin
药品：Placebo identical to BI10773 high dose
placebo tablets once daily
药品：Placebo identical to Sitagliptin 100mg
placebo tablets once daily
药品：Placebo identical to BI10773 low dose
placebo tablets once daily
有源比较器：Sitagliptin 100 mg
Patients receive Sitagliptin 100 mg tablets once daily
药品：Placebo identical to BI10773 high dose
placebo tablets once daily
药品：Placebo identical to BI10773 low dose
placebo tablets once daily
药品：Sitagliptin
Sitagliptin tablets 100 mg once daily
实验性的：BI 10773 high dose open label
Patients receive BI 10773 high dose tablets open label once daily
药品：BI 10773 open label
Patients receive BI 10773 high dose tablets open label once daily

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
Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks
大体时间：Baseline and day 169

The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Baseline and day 169

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline to Week 24 in Body Weight
大体时间：Baseline and day 169

The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.
Baseline and day 169
Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)
大体时间：Baseline and week 24

The term "baseline" refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).

In this endpoint, the "measured values" show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.

For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored.
Baseline and week 24

其他结果措施

结果测量
措施说明
大体时间
Confirmed Hypoglycaemic Adverse Events
大体时间：From first drug intake until 7 days after last medication intake, up to 219 days

Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required.

Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category.
From first drug intake until 7 days after last medication intake, up to 219 days

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

Boehringer Ingelheim

合作者

Eli Lilly and Company

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

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7月1日

初级完成 (实际的)

2012年3月1日

研究注册日期

首次提交

2010年7月29日

首先提交符合 QC 标准的

2010年8月6日

首次发布 (估计)

2010年8月9日

研究记录更新

最后更新发布 (估计)

2014年6月16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

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1245.20
  • 2009-016243-20 (EudraCT编号：EudraCT)

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.

BI 10773的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Lebanon

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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