Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus
2009年8月25日 更新者:Sanofi
Evaluation of Efficacy and Safety of HMR1964 (Insulin Glulisine) in Subjects With Type 1 Diabetes Mellitus; Insulin Lispro Controlled, Open, Randomized, Parallel Group, Non-inferiority Study, for 28 Weeks
- To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint.
- To compare the safety of HMR1964 with insulin lispro.
研究概览
详细说明
- To compare HMR1964 with insulin lispro in terms of the change in HbA1C from baseline to week 12 and week 28; consecutive change in HbA1C by every 4 weeks, blood glucose parameters, symptomatic hypoglycemia and insulin doses (rapid-acting, basal and total).
- To collect 6-month safety data of HMR1964.
研究类型
介入性
注册
250
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
-
-
-
Tokyo、日本
- Sanofi-Aventis
-
-
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:
- Men or women with type 1 diabetes mellitus, an HbA1C range of >=6.0 - =<11.0%, and on a basal-bolus insulin regimen. They must have had at least 1 year of continuous insulin treatment at the date of informed consent.
Exclusion Criteria:
- Subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent
- Subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent
- Subjects who were treated with another investigational product within 12 weeks prior to informed consent
- Subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol
- Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or systemic disease making implementation of the protocol or interpretation of the study results difficult
- Subjects who have undergone pancreatectomy or pancreas/islet cell transplant
- Night shift workers
- Subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study
- Subjects who have previously been treated with HMR1964
- Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
- Female subjects who are possibly pregnant [female subjects of reproductive potential who have serum human chorionic gonadotropin (hCG) level > 0.7 mIU/mL as determined by central laboratory, SRL Medisearch Inc., during screening phase]
- Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period
- Subjects with history of alcohol abuse
- Subjects with hypersensitivity to insulin preparations
- Subjects with impaired hepatic function (SGOT or SGPT ³=<80 IU/L determined by central laboratory, SRL Medisearch Inc., during screening phase) or impaired renal function (serum creatinine =<2.0 mg/dL determined by central laboratory, SRL Medisearch Inc., during screening phase)
- Subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason
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)
研究衡量的是什么?
主要结果指标
结果测量 |
---|
Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro
|
次要结果测量
结果测量 |
---|
6-month safety data
|
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
调查人员
- 研究主任:Masayoshi KOYAMA、Sanofi
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。
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
2004年12月1日
初级完成
2022年12月7日
研究完成
2022年12月7日
研究注册日期
首次提交
2006年2月10日
首先提交符合 QC 标准的
2006年2月10日
首次发布 (估计)
2006年2月13日
研究记录更新
最后更新发布 (估计)
2009年8月26日
上次提交的符合 QC 标准的更新
2009年8月25日
最后验证
2009年3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.
糖尿病,1 型的临床试验
谷赖胰岛素的临床试验
-
Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbH完全的
-
Mannkind Corporation完全的
-
Julphar Gulf Pharmaceutical IndustriesProfil Institut für Stoffwechselforschung GmbH完全的