Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
2017年6月8日 更新者：Novo Nordisk A/S
A 20-week Study Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients Uncontrolled on NPH Insulin
This trial is conducted in Africa and Asia.
The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.
研究概览
研究类型
介入性
注册 (实际的)
155
阶段
- 第四阶段
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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Bandung、印度尼西亚、40161
- Novo Nordisk Investigational Site
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Malang、印度尼西亚、65111
- Novo Nordisk Investigational Site
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Alexandria、埃及、21131
- Novo Nordisk Investigational Site
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Beni-Suef、埃及、62511
- Novo Nordisk Investigational Site
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Cairo、埃及、11562
- Novo Nordisk Investigational Site
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Casablanca、摩洛哥、20100
- Novo Nordisk Investigational Site
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Marrakech、摩洛哥、40000
- Novo Nordisk Investigational Site
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Jeddah、沙特阿拉伯、80215
- Novo Nordisk Investigational Site
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Riyadh、沙特阿拉伯、11211
- Novo Nordisk Investigational Site
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Riyadh、沙特阿拉伯、11426
- Novo Nordisk Investigational Site
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Taif、沙特阿拉伯、21944
- Novo Nordisk Investigational Site
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Tunis、突尼斯、1007
- Novo Nordisk Investigational Site
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Tunis、突尼斯、1008
- Novo Nordisk Investigational Site
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Ha Noi City、越南
- Novo Nordisk Investigational Site
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Ho Chi Minh City、越南
- Novo Nordisk Investigational Site
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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
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:
- Diagnosed with type 2 diabetes for a minimum of 12 months prior to screening
- Currently treated with a NPH insulin for at least 3 months prior to screening
- Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The metformin treatment must have been stable for at least 2 months prior to screening
- HbA1c between 7.0% and 10.0% (both inclusive). (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)
- Body Mass Index (BMI) below or equal to 40.0 kg/m^2
- Able and willing to eat at least 2 main meals each day during the trial
- Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol
- Experience in performing self-measured plasma glucose (SMPG)
Exclusion Criteria:
- Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1) receptor agonists or pramlintide within the last 3 months prior to screening
- Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper referenced limit. (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)
- Impaired kidney function with serum creatinine above or equal to 133 µmol/L (1.5 mg/dL) for males and above or equal to 124 µmol/L (1.4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)
- Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
- Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- Known proliferative retinopathy or maculopathy requiring treatment
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 |
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实验性的：主题驱动的滴定
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Dose individually adjusted by the subjects themselves according to the titration algorithm every second week.
Administered subcutaneously (s.c., under the skin) twice daily.
Dose individually adjusted according to the directions given by the investigator.
Administered subcutaneously (s.c., under the skin) twice daily.
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实验性的：Investigator-driven titration
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Dose individually adjusted by the subjects themselves according to the titration algorithm every second week.
Administered subcutaneously (s.c., under the skin) twice daily.
Dose individually adjusted according to the directions given by the investigator.
Administered subcutaneously (s.c., under the skin) twice daily.
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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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Change in HbA1c From Baseline
大体时间：Week 0, week 20
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Change in HbA1c (%) from baseline to the end of the treatment period.
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Week 0, week 20
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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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Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline
大体时间：Week 0, week 20
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Change in FPG (laboratory values) from baseline to the end of the treatment period
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Week 0, week 20
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Number of Hypoglycaemic Episodes During the Trial From Baseline
大体时间：Week 20
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The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level 3.1 mmol/L [56 mg/dL]) during the trial.
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Week 20
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Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
大体时间：Week 0, week 20
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Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores.
The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health).
The scores were transformed to a 0-100 scale with higher scores indicating a better health state.
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Week 0, week 20
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Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden
大体时间：Week 0, week 20
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Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores.
The score measured treatment satisfaction which included a subscale score -treatment burden.
The scores were transformed to a 0-100 scale with higher scores indicating a better health state.
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Week 0, week 20
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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。
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 (实际的)
2012年5月26日
初级完成 (实际的)
2015年7月9日
研究完成 (实际的)
2015年7月9日
研究注册日期
首次提交
2012年4月30日
首先提交符合 QC 标准的
2012年4月30日
首次发布 (估计)
2012年5月2日
研究记录更新
最后更新发布 (实际的)
2017年7月11日
上次提交的符合 QC 标准的更新
2017年6月8日
最后验证
2017年6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.