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Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment

2019年3月6日 更新者：Novo Nordisk A/S

Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.

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)

279

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

  • 乌克兰
      • Kharkiv、乌克兰、61000
        • Novo Nordisk Investigational Site
      • Kiev、乌克兰、04053
        • Novo Nordisk Investigational Site
      • Kyiv、乌克兰、04114
        • Novo Nordisk Investigational Site
      • Vinnytsia、乌克兰、21010
        • Novo Nordisk Investigational Site
      • Zaporizhia、乌克兰、69600
        • Novo Nordisk Investigational Site
  • 俄罗斯联邦
      • Barnaul、俄罗斯联邦、656045
        • Novo Nordisk Investigational Site
      • Kazan、俄罗斯联邦、420043
        • Novo Nordisk Investigational Site
      • Kursk、俄罗斯联邦、305035
        • Novo Nordisk Investigational Site
      • Moscow、俄罗斯联邦、117036
        • Novo Nordisk Investigational Site
      • Moscow、俄罗斯联邦、123448
        • Novo Nordisk Investigational Site
      • Moscow、俄罗斯联邦、127411
        • Novo Nordisk Investigational Site
      • Nizhniy Novgorod、俄罗斯联邦、603126
        • Novo Nordisk Investigational Site
      • Penza、俄罗斯联邦、440026
        • Novo Nordisk Investigational Site
      • Saint-Petersburg、俄罗斯联邦、195257
        • Novo Nordisk Investigational Site
      • Saint-Petersburg、俄罗斯联邦、194358
        • Novo Nordisk Investigational Site
      • Saint-Petersburg、俄罗斯联邦、199034
        • Novo Nordisk Investigational Site
      • Samara、俄罗斯联邦、443067
        • Novo Nordisk Investigational Site
      • Saratov、俄罗斯联邦、410039
        • Novo Nordisk Investigational Site
      • Saratov、俄罗斯联邦、410053
        • Novo Nordisk Investigational Site
      • Saratov、俄罗斯联邦、410031
        • Novo Nordisk Investigational Site
      • Smolensk、俄罗斯联邦、214019
        • Novo Nordisk Investigational Site
      • Volgograd、俄罗斯联邦、400138
        • Novo Nordisk Investigational Site
  • 法国
      • Brest、法国、29609
        • Novo Nordisk Investigational Site
      • LA ROCHE-sur-YON cedex 9、法国、85295
        • Novo Nordisk Investigational Site
      • LA ROCHELLE cedex、法国、17019
        • Novo Nordisk Investigational Site
      • Pointe À Pitre、法国、97159
        • Novo Nordisk Investigational Site
      • Strasbourg、法国、67000
        • Novo Nordisk Investigational Site
  • 波兰
      • Bialystok、波兰、15-435
        • Novo Nordisk Investigational Site
      • Bialystok、波兰、15-381
        • Novo Nordisk Investigational Site
      • Gdansk、波兰、80-546
        • Novo Nordisk Investigational Site
      • Katowice、波兰、40-767
        • Novo Nordisk Investigational Site
      • Krakow、波兰、31-261
        • Novo Nordisk Investigational Site
      • Poznan、波兰、60-569
        • Novo Nordisk Investigational Site
      • Poznan、波兰、60-111
        • Novo Nordisk Investigational Site
      • Zabrze、波兰、41-800
        • Novo Nordisk Investigational Site
  • 美国
    • California
      • Concord、California、美国、94520
        • Novo Nordisk Investigational Site
      • La Jolla、California、美国、92037
        • Novo Nordisk Investigational Site
      • Los Angeles、California、美国、90057
        • Novo Nordisk Investigational Site
      • Monterey、California、美国、93940
        • Novo Nordisk Investigational Site
      • San Diego、California、美国、92111
        • Novo Nordisk Investigational Site
      • San Ramon、California、美国、94583
        • Novo Nordisk Investigational Site
      • Torrance、California、美国、90502
        • Novo Nordisk Investigational Site
      • Tustin、California、美国、92780
        • Novo Nordisk Investigational Site
      • Ventura、California、美国、93003
        • Novo Nordisk Investigational Site
    • Colorado
      • Golden、Colorado、美国、80401
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach、Florida、美国、33472
        • Novo Nordisk Investigational Site
      • Jacksonville、Florida、美国、32216
        • Novo Nordisk Investigational Site
      • Miami、Florida、美国、33156
        • Novo Nordisk Investigational Site
      • Pembroke Pines、Florida、美国、33027
        • Novo Nordisk Investigational Site
      • Plantation、Florida、美国、33324
        • Novo Nordisk Investigational Site
      • Saint Petersburg、Florida、美国、33711
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta、Georgia、美国、30303
        • Novo Nordisk Investigational Site
      • Roswell、Georgia、美国、30076
        • Novo Nordisk Investigational Site
    • Indiana
      • Avon、Indiana、美国、46123
        • Novo Nordisk Investigational Site
      • Franklin、Indiana、美国、46131
        • Novo Nordisk Investigational Site
      • Greenfield、Indiana、美国、46140
        • Novo Nordisk Investigational Site
      • Muncie、Indiana、美国、47304
        • Novo Nordisk Investigational Site
    • Louisiana
      • Slidell、Louisiana、美国、70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville、Maryland、美国、20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Springfield、Massachusetts、美国、01199
        • Novo Nordisk Investigational Site
    • Michigan
      • Buckley、Michigan、美国、49620
        • Novo Nordisk Investigational Site
      • Southfield、Michigan、美国、48034-7661
        • Novo Nordisk Investigational Site
    • Montana
      • Great Falls、Montana、美国、59405
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua、New Hampshire、美国、03063
        • Novo Nordisk Investigational Site
    • New York
      • Rosedale、New York、美国、11422
        • Novo Nordisk Investigational Site
      • Staten Island、New York、美国、10301
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greenville、North Carolina、美国、27834
        • Novo Nordisk Investigational Site
      • Mooresville、North Carolina、美国、28117
        • Novo Nordisk Investigational Site
    • Ohio
      • Franklin、Ohio、美国、45005
        • Novo Nordisk Investigational Site
      • Mason、Ohio、美国、45040-6815
        • Novo Nordisk Investigational Site
      • Wadsworth、Ohio、美国、44281-9236
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • McMurray、Pennsylvania、美国、15317
        • Novo Nordisk Investigational Site
      • Norristown、Pennsylvania、美国、19401
        • Novo Nordisk Investigational Site
      • Philadelphia、Pennsylvania、美国、19107
        • Novo Nordisk Investigational Site
    • Rhode Island
      • East Providence、Rhode Island、美国、02914
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga、Tennessee、美国、37411
        • Novo Nordisk Investigational Site
      • Chattanooga、Tennessee、美国、37404-1192
        • Novo Nordisk Investigational Site
      • Kingsport、Tennessee、美国、37660
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo、Texas、美国、79106
        • Novo Nordisk Investigational Site
      • Lubbock、Texas、美国、79423
        • Novo Nordisk Investigational Site
      • Sugar Land、Texas、美国、77479
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News、Virginia、美国、23606
        • Novo Nordisk Investigational Site
      • Richmond、Virginia、美国、23294
        • Novo Nordisk Investigational Site
      • Richmond、Virginia、美国、23219
        • Novo Nordisk Investigational Site
      • Richmond、Virginia、美国、23298
        • Novo Nordisk Investigational Site
      • Winchester、Virginia、美国、22601
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53209
        • Novo Nordisk Investigational Site
  • 英国
      • Bristol、英国、BS10 5NB
        • Novo Nordisk Investigational Site
      • Dundee、英国、DD1 9SY
        • Novo Nordisk Investigational Site
      • Edinburgh、英国、EH4 2XU
        • Novo Nordisk Investigational Site
      • Hull、英国、HU3 2RW
        • Novo Nordisk Investigational Site
      • Leicester、英国、LE5 4PW
        • Novo Nordisk Investigational Site
      • Letchworth、英国、SG6 4UB
        • Novo Nordisk Investigational Site
      • London、英国、E1 2EF
        • Novo Nordisk Investigational Site
      • London、英国、SE5 9RT
        • Novo Nordisk Investigational Site
      • Swansea、英国、SA6 6NL
        • Novo Nordisk 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 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:

  • Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
  • HbA1c 7-10% (both inclusive)
  • Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit
  • Body Mass Index (BMI) 20-45 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
  • Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of the investigator
  • Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram))
  • Heart failure defined as New York Heart Association (NYHA) class IV
  • A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg
  • Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
  • Use of immunosuppressive treatment within 90 days prior to screening
  • Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  • Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator

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
安慰剂比较：安慰剂
药品：placebo
Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.
实验性的：里拉 1.8 毫克
药品：liraglutide
1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

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
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)
大体时间：Week 0, Week 26
Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.
Week 0, Week 26

次要结果测量

结果测量
措施说明
大体时间
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
大体时间：At week 26
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.
At week 26
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment
大体时间：At week 26
Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.
At week 26
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles
大体时间：Week 0, week 26
SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.
Week 0, week 26
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)
大体时间：Week 0, week 26
Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.
Week 0, week 26
Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)
大体时间：Week 0, week 26
Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.
Week 0, week 26

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

Novo Nordisk A/S

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 (实际的)

2012年6月14日

初级完成 (实际的)

2013年8月20日

研究完成 (实际的)

2013年8月20日

研究注册日期

首次提交

2012年6月13日

首先提交符合 QC 标准的

2012年6月13日

首次发布 (估计)

2012年6月15日

研究记录更新

最后更新发布 (实际的)

2019年3月19日

上次提交的符合 QC 标准的更新

2019年3月6日

最后验证

2019年3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

  • NN2211-3916
  • 2011-002968-24 (EudraCT编号)
  • U1111-1122-3303 (其他标识符：WHO)

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.

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