A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
2015年3月19日 更新者：AstraZeneca
An Open Label Study Comparing Exenatide With Basal Insulin in Achieving an HbA1c of ≤ 7.4% With Minimum Weight Gain, in Type 2 Diabetes Patients Who Are Not Achieving Adequate HbA1c Control on Oral Anti Diabetic Therapies Alone
This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.
研究概览
研究类型
介入性
注册 (实际的)
235
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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Aberdeen、英国
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Bath、英国
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Blackburn、英国
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Bolton、英国
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Bournemouth、英国
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Bristol、英国
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Chippenham、英国
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Edinburgh、英国
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Glasgow、英国
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Haywards Heath、英国
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High Wycombe、英国
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Hull、英国
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Ipswich、英国
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Kent、英国
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Leicester、英国
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Liverpool、英国
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Livingstone、英国
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London、英国
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Manchester、英国
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Middlesborough、英国
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Norwich、英国
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Nottingham、英国
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Oldham、英国
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Oxford、英国
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Plymouth、英国
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Rochdale、英国
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Salford、英国
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Swansea、英国
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Torquay、英国
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Wakefield、英国
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Wirral、英国
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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 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
- Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months.
- HbA1c between 7.5% and 10.0%.
- BMI >27.
Exclusion Criteria:
- Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study.
- Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study.
- Treatment with the following medications: *Insulin as outpatient therapy within last 3 months; *Meglitinides, or acarbose within the last 3 months; *Regular use of any drugs that directly affect gastrointestinal motility; *Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; *Anti-obesity agent use within the last 3 months.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
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：1个
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皮下注射，5mcg 或 10mcg，每天两次
其他名称：
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有源比较器：2个
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subcutaneous injection, titrated to target blood glucose level, once a day
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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Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
大体时间：26 weeks
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Composite endpoint evaluating effect of treatment on glycemic control and weight
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26 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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Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
大体时间：26 weeks
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Composite endpoint evaluating effect of treatment on glycemic control and weight
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26 weeks
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Change in Fasting Serum Glucose
大体时间：26 weeks
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Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
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26 weeks
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Percent of Patients Achieving HbA1c ≤ 7.4%
大体时间：26 weeks
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Percent of patients achieving specified HbA1c target at endpoint
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26 weeks
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Percent of Patients Achieving HbA1c < 7%
大体时间：26 weeks
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Percent of patients achieving specified HbA1c target at endpoint
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26 weeks
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Percent of Patients Achieving HbA1c < 6.5%
大体时间：26 weeks
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Percent of patients achieving specified HbA1c target at endpoint
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26 weeks
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Change in 7 Point Self Monitored Blood Glucose Profile
大体时间：26 weeks
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Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
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26 weeks
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Change in Body Mass Index (BMI)
大体时间：26 weeks
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Change in BMI from baseline to endpoint
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26 weeks
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Change in Waist Circumference
大体时间：26 Weeks
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Change in waist circumference from baseline to endpoint
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26 Weeks
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Change in Waist-to-hip Ratio
大体时间：26 weeks
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Change in waist-to-hip ratio from baseline to endpoint
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26 weeks
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Change in Body Weight
大体时间：26 weeks
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Change in body weight from baseline to endpoint
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26 weeks
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Percent Change in Body Weight
大体时间：26 Weeks
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Percent change in baseline body weight at endpoint
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26 Weeks
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Percent of Patients Achieving 5% Weight Loss
大体时间：26 weeks
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Percent of patients who lost at least 5% of baseline body weight at endpoint
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26 weeks
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Percent of Patients Achieving 10% Weight Loss
大体时间：26 weeks
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Percent of patients who lost at least 10% of baseline body weight at endpoint
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26 weeks
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Change in Systolic Blood Pressure
大体时间：26 weeks
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Change in systolic blood pressure from baseline to endpoint
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26 weeks
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Change in Diastolic Blood Pressure
大体时间：26 weeks
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Change in diastolic blood pressure from baseline to endpoint
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26 weeks
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Change in Fasting Serum Total Cholesterol (TC)
大体时间：26 weeks
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Change in TC from baseline to endpoint
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26 weeks
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Change in High Density Lipoprotein (HDL) Cholesterol
大体时间：26 weeks
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Change in HDL cholesterol from baseline to endpoint
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26 weeks
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Change in TC to HDL Cholesterol Ratio
大体时间：26 weeks
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Change in TC to HDL cholesterol ratio from baseline to endpoint
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26 weeks
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Change in Fasting Serum Triglycerides
大体时间：26 weeks
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Change in fasting serum triglycerides from baseline to endpoint
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26 weeks
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Change in Low Density Lipoprotein (LDL) Cholesterol
大体时间：26 weeks
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Change in LDL cholesterol from baseline to endpoint
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26 weeks
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Change in Apolipoprotein-B
大体时间：26 weeks
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Change in apolipoprotein-B from baseline to endpoint
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26 weeks
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Incidence of Hypoglycemic Episodes
大体时间：26 weeks
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Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study
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26 weeks
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Incidence of Nocturnal Hypoglycemic Episodes
大体时间：26 weeks
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Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study
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26 weeks
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Incidence of Severe Hypoglycemic Episodes
大体时间：26 weeks
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Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study
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26 weeks
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Hypoglycemic Rate Per 30 Days
大体时间：26 weeks
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Number of hypoglycemic episodes per patient adjusted per 30 days
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26 weeks
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Nocturnal Hypoglycemic Rate Per 30 Days
大体时间：26 weeks
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Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days
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26 weeks
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Severe Hypoglycemic Rate Per 30 Days
大体时间：26 weeks
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Number of severe hypoglycemic episodes per patient adjusted per 30 days
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26 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。
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
- Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
- Davies MJ, Donnelly R, Barnett AH, Jones S, Nicolay C, Kilcoyne A. Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study. Diabetes Obes Metab. 2009 Dec;11(12):1153-62. doi: 10.1111/j.1463-1326.2009.01154.x.
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
2006年6月1日
初级完成 (实际的)
2008年4月1日
研究完成 (实际的)
2008年4月1日
研究注册日期
首次提交
2006年8月2日
首先提交符合 QC 标准的
2006年8月2日
首次发布 (估计)
2006年8月4日
研究记录更新
最后更新发布 (估计)
2015年4月7日
上次提交的符合 QC 标准的更新
2015年3月19日
最后验证
2015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.