LIraglutide and Beta-cell RepAir (LIBRA) Study (LIBRA)
2014年9月10日 更新者：Mount Sinai Hospital, Canada
A Randomized Controlled Study Assessing the Effect of Liraglutide on the Preservation of Beta-Cell Function in Patients With Type 2 Diabetes Mellitus: The LIraglutide and Beta-cell RepAir (LIBRA) Study
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body).
We propose a double-blind, randomized controlled study comparing the effect of liraglutide (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM.
This study may demonstrate an important beta-cell protective capacity of liraglutide.
研究概览
详细说明
In this study, patients with type 2 diabetes who meet randomization criteria will be randomized to either liraglutide or placebo, with serial assessment of beta-cell function over 48 weeks follow-up.
The hypothesis under study is whether liraglutide can preserve beta-cell function.
研究类型
介入性
注册 (实际的)
63
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
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Ontario
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Toronto、Ontario、加拿大、M5G1X5
- Mount Sinai Hospital
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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
30年 至 75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:
- men and women between the ages of 30 and 75 years inclusive
- physician-diagnosed type 2 diabetes of </= 7 years duration
- negative for anti-GAD antibodies
- on 0-2 oral anti-diabetic medications
- A1c at screening between 5.5% and 9.0% inclusive, if on oral anti-diabetic medications, or between 6.0% and 10.0% inclusive, if not on oral anti-diabetic medications
Exclusion Criteria:
- use of insulin, GLP-1 agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitor
- type 1 diabetes or secondary forms of diabetes
- major illness with life expectancy < 5 years
- involvement in another study requiring drug therapy
- hypersensitivity to insulin, liraglutide, or metformin
- renal dysfunction
- hepatic dysfunction
- history of pancreatitis
- family or personal history of Multiple Endocrine Neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma
- personal history of non-familial medullary thyroid carcinoma
- malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
- excessive alcohol consumption
- unwillingness to undergo multiple daily insulin injection therapy
- unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy
- congestive heart failure
- pregnancy
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：四人间
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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placebo administered as once daily sc injection
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实验性的：利拉鲁肽
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Liraglutide administered as once daily sc injection
其他名称：
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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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Preservation of beta-cell function measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2)
大体时间：48-weeks
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ISSI-2 is a validated OGTT-derived measure of beta-cell function analogous to the disposition index obtained from the intravenous glucose tolerance test.
ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve (AUCins) to the area-under-the-glucose curve (AUCgluc) and (ii) insulin sensitivity measured by the Matsuda index.
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48-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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Glycemic Control
大体时间：48 weeks
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48 weeks
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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。
合作者
调查人员
- 首席研究员：Ravi Retnakaran, MD、Mount Sinai Hospital, Canada
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
- Stein CM, Kramer CK, Zinman B, Choi H, Opsteen C, Retnakaran R. Clinical predictors and time course of the improvement in beta-cell function with short-term intensive insulin therapy in patients with Type 2 diabetes. Diabet Med. 2015 May;32(5):645-52. doi: 10.1111/dme.12671. Epub 2015 Jan 7.
- Nunez Lopez YO, Retnakaran R, Zinman B, Pratley RE, Seyhan AA. Predicting and understanding the response to short-term intensive insulin therapy in people with early type 2 diabetes. Mol Metab. 2019 Feb;20:63-78. doi: 10.1016/j.molmet.2018.11.003. Epub 2018 Nov 16.
- Kramer CK, Zinman B, Choi H, Connelly PW, Retnakaran R. Impact of the Glucagon Assay When Assessing the Effect of Chronic Liraglutide Therapy on Glucagon Secretion. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2729-2733. doi: 10.1210/jc.2017-00928.
- Kramer CK, Zinman B, Choi H, Retnakaran R. Predictors of sustained drug-free diabetes remission over 48 weeks following short-term intensive insulin therapy in early type 2 diabetes. BMJ Open Diabetes Res Care. 2016 Aug 1;4(1):e000270. doi: 10.1136/bmjdrc-2016-000270. eCollection 2016.
- Kramer CK, Zinman B, Choi H, Connelly PW, Retnakaran R. The Impact of Chronic Liraglutide Therapy on Glucagon Secretion in Type 2 Diabetes: Insight From the LIBRA Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3702-9. doi: 10.1210/jc.2015-2725. Epub 2015 Jul 31.
- Kramer CK, Zinman B, Choi H, Retnakaran R. Effect of Short-term Intensive Insulin Therapy on Post-challenge Hyperglucagonemia in Early Type 2 Diabetes. J Clin Endocrinol Metab. 2015 Aug;100(8):2987-95. doi: 10.1210/jc.2015-1947. Epub 2015 Jun 16.
- Retnakaran R, Kramer CK, Choi H, Swaminathan B, Zinman B. Liraglutide and the preservation of pancreatic beta-cell function in early type 2 diabetes: the LIBRA trial. Diabetes Care. 2014 Dec;37(12):3270-8. doi: 10.2337/dc14-0893. Epub 2014 Sep 23.
- Kramer CK, Choi H, Zinman B, Retnakaran R. Glycemic variability in patients with early type 2 diabetes: the impact of improvement in beta-cell function. Diabetes Care. 2014 Apr;37(4):1116-23. doi: 10.2337/dc13-2591. Epub 2014 Feb 18.
- Kramer CK, Choi H, Zinman B, Retnakaran R. Determinants of reversibility of beta-cell dysfunction in response to short-term intensive insulin therapy in patients with early type 2 diabetes. Am J Physiol Endocrinol Metab. 2013 Dec 1;305(11):E1398-407. doi: 10.1152/ajpendo.00447.2013. Epub 2013 Oct 15.
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
2011年1月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2014年5月1日
研究注册日期
首次提交
2011年1月4日
首先提交符合 QC 标准的
2011年1月4日
首次发布 (估计)
2011年1月5日
研究记录更新
最后更新发布 (估计)
2014年9月12日
上次提交的符合 QC 标准的更新
2014年9月10日
最后验证
2014年9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.