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A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™)

2017年3月9日 更新者：Novo Nordisk A/S

A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes (BEGIN™: ONCE)

This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

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)

833

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
    • Anhui
      • Hefei、Anhui、中国、230001
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing、Beijing、中国、100029
        • Novo Nordisk Investigational Site
      • Beijing、Beijing、中国、100730
        • Novo Nordisk Investigational Site
      • Beijing、Beijing、中国、100853
        • Novo Nordisk Investigational Site
      • Beijing、Beijing、中国、100700
        • Novo Nordisk Investigational Site
      • Beijing、Beijing、中国、100039
        • Novo Nordisk Investigational Site
      • Beijing、Beijing、中国、100191
        • Novo Nordisk Investigational Site
    • Chongqing
      • ChongQing、Chongqing、中国、404000
        • Novo Nordisk Investigational Site
      • Chongqing、Chongqing、中国、400010
        • Novo Nordisk Investigational Site
      • Chongqing、Chongqing、中国、400016
        • Novo Nordisk Investigational Site
    • Fujian
      • Fuzhou、Fujian、中国、350025
        • Novo Nordisk Investigational Site
    • Guangdong
      • Guangzhou、Guangdong、中国、510120
        • Novo Nordisk Investigational Site
    • Guangxi
      • Nanning、Guangxi、中国、530007
        • Novo Nordisk Investigational Site
    • Guizhou
      • Guiyang、Guizhou、中国、550004
        • Novo Nordisk Investigational Site
    • Hebei
      • Shijiazhuang、Hebei、中国、050051
        • Novo Nordisk Investigational Site
      • Shijiazhuang、Hebei、中国、050082
        • Novo Nordisk Investigational Site
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150086
        • Novo Nordisk Investigational Site
    • Hubei
      • Wuhan、Hubei、中国、430034
        • Novo Nordisk Investigational Site
      • Wuhan、Hubei、中国、430030
        • Novo Nordisk Investigational Site
    • Hunan
      • Yueyang、Hunan、中国、414000
        • Novo Nordisk Investigational Site
    • Jiangsu
      • Yangzhou、Jiangsu、中国、225001
        • Novo Nordisk Investigational Site
      • Zhenjiang、Jiangsu、中国、212001
        • Novo Nordisk Investigational Site
    • Jiangxi
      • Nanchang、Jiangxi、中国、330006
        • Novo Nordisk Investigational Site
    • Jilin
      • Changchun、Jilin、中国、130041
        • Novo Nordisk Investigational Site
      • Siping、Jilin、中国、136000
        • Novo Nordisk Investigational Site
    • Liaoning
      • Shenyang、Liaoning、中国、110021
        • Novo Nordisk Investigational Site
      • Shenyang、Liaoning、中国、110004
        • Novo Nordisk Investigational Site
    • Shaanxi
      • Xi'an、Shaanxi、中国、710032
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai、Shanghai、中国、200040
        • Novo Nordisk Investigational Site
      • Shanghai、Shanghai、中国、200072
        • Novo Nordisk Investigational Site
    • Yunnan
      • Kunming、Yunnan、中国、650101
        • Novo Nordisk Investigational Site
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • Novo Nordisk Investigational Site
      • Wenzhou、Zhejiang、中国、325000
        • Novo Nordisk Investigational Site
  • 乌克兰
      • Dnepropetrovsk、乌克兰、49005
        • Novo Nordisk Investigational Site
      • Dnepropetrovsk、乌克兰、49038
        • Novo Nordisk Investigational Site
      • Kiev、乌克兰、04114
        • Novo Nordisk Investigational Site
      • Mykolaiv、乌克兰、54003
        • Novo Nordisk Investigational Site
      • Vinnitsa、乌克兰、21010
        • Novo Nordisk Investigational Site
  • 加拿大
      • Quebec、加拿大、G3K 2P8
        • Novo Nordisk Investigational Site
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4L7
        • Novo Nordisk Investigational Site
    • British Columbia
      • Burnaby、British Columbia、加拿大、V5G 1T4
        • Novo Nordisk Investigational Site
      • Surrey、British Columbia、加拿大、V3S 2N6
        • Novo Nordisk Investigational Site
      • Victoria、British Columbia、加拿大、V8V 4A1
        • Novo Nordisk Investigational Site
    • Ontario
      • Burlington、Ontario、加拿大、L7M 4Y1
        • Novo Nordisk Investigational Site
      • London、Ontario、加拿大、N5W 6A2
        • Novo Nordisk Investigational Site
      • London、Ontario、加拿大、N6P 1A9
        • Novo Nordisk Investigational Site
      • Newmarket、Ontario、加拿大、L3Y 5G8
        • Novo Nordisk Investigational Site
      • Sarnia、Ontario、加拿大、N7T 4X3
        • Novo Nordisk Investigational Site
      • Strathroy、Ontario、加拿大、N7G 1Y7
        • Novo Nordisk Investigational Site
    • Quebec
      • Trois Rivieres、Quebec、加拿大、G8T7A1
        • Novo Nordisk Investigational Site
  • 南非
    • Eastern Cape
      • George、Eastern Cape、南非、6529
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg、Gauteng、南非、2193
        • Novo Nordisk Investigational Site
      • Johannesburg、Gauteng、南非、1812
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban、KwaZulu-Natal、南非、4001
        • Novo Nordisk Investigational Site
      • Durban、KwaZulu-Natal、南非、4091
        • Novo Nordisk Investigational Site
  • 巴西
      • Porto Alegre、巴西、90035-170
        • Novo Nordisk Investigational Site
      • São Paulo、巴西、04022-002
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • São Paulo、Sao Paulo、巴西、01244-030
        • Novo Nordisk Investigational Site
  • 罗马尼亚
      • Bucharest、罗马尼亚、020614
        • Novo Nordisk Investigational Site
      • Buzau、罗马尼亚、120203
        • Novo Nordisk Investigational Site
      • Galati、罗马尼亚、800578
        • Novo Nordisk Investigational Site
      • Sibiu、罗马尼亚、550176
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea、Bihor、罗马尼亚、410469
        • Novo Nordisk Investigational Site
  • 美国
    • California
      • Anaheim、California、美国、92801
        • Novo Nordisk Investigational Site
      • Lomita、California、美国、90717
        • Novo Nordisk Investigational Site
      • Los Angeles、California、美国、90057
        • Novo Nordisk Investigational Site
    • Colorado
      • Golden、Colorado、美国、80401
        • Novo Nordisk Investigational Site
    • Florida
      • Clearwater、Florida、美国、33765
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago、Illinois、美国、60607
        • Novo Nordisk Investigational Site
    • Kentucky
      • Crestview Hills、Kentucky、美国、41017-3464
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie、Louisiana、美国、70002
        • Novo Nordisk Investigational Site
    • Michigan
      • Troy、Michigan、美国、48098
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield、Missouri、美国、63017
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua、New Hampshire、美国、03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Toms River、New Jersey、美国、08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Smithtown、New York、美国、11787
        • Novo Nordisk Investigational Site
    • South Carolina
      • Simpsonville、South Carolina、美国、29681
        • Novo Nordisk Investigational Site
    • Tennessee
      • Jackson、Tennessee、美国、38305
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas、Texas、美国、75230
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News、Virginia、美国、23606
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha、Wisconsin、美国、53142
        • 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 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:

  • Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
  • Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
  • Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
  • HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
  • BMI (Body Mass Index) below or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
  • Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
  • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial product(s) or related products

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Insulin Degludec
药品：Insulin Degludec
Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.
其他名称：
  • NN1250
实验性的：Insulin Glargine
药品：Insulin Glargine
Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

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 HbA1c (%) (Analysed by Central Laboratory)
大体时间：Week 0, week 26
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Week 0, week 26

次要结果测量

结果测量
措施说明
大体时间
Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
大体时间：On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).
On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)
大体时间：Week 0, week 26
Change from baseline in FPG after 26 weeks of treatment.
Week 0, week 26
Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)
大体时间：Week 26
Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.
Week 26
Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes
大体时间：Week 26
A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.
Week 26
Number of Treatment Emergent AEs (Adverse Events)
大体时间：On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)
Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)
On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)

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)

2013年6月2日

初级完成 (实际的)

2014年5月15日

研究完成 (实际的)

2014年5月15日

研究注册日期

首次提交

2013年5月6日

首先提交符合 QC 标准的

2013年5月6日

首次发布 (估计)

2013年5月8日

研究记录更新

最后更新发布 (实际的)

2017年4月7日

上次提交的符合 QC 标准的更新

2017年3月9日

最后验证

2017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

  • NN1250-3587
  • U1111-1121-5325 (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.

Insulin Degludec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 Norway

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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