24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes
2009年4月10日 更新者：GlaxoSmithKline
Comparison of the Effects of Rosiglitazone and Glimepiride, Both Given in Combination With Metformin, on 24-Hour Glycemia in Type 2 Diabetes Patients Not Controlled With Metformin Alone. A 3-Month Multicentre, Randomized, Parallel-Group, Open-Label Study.
A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients.
The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride).
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
23
阶段
- 第四阶段
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
40年 至 80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:
- Males and females aged 40 to 80 years
- Diagnosis of type 2 diabetes mellitus for at least 6 months
- Body mass index (BMI) ≥25kg/m2
- 7%≥HbA1c ≤ 9% at visit 2
- Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1
- Female subjects must be non-pregnant, post-menopausal, surgically sterile or using effective contraceptive measures
- Written informed consent
Exclusion Criteria:
- Use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening
- Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure
- Subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis
- Subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1
- Subjects with a history of severe hypoglycaemia
- Anemia defined by haemoglobin concentration <11.0g/dL for males or <10.0g/dL for females
- Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135µmol/L in males and ≥110µmol/L in females
- Presence of clinically significant hepatic disease (i.e. ALT, AST, total bilirubin or alkaline phosphatase >2.5 times the upper limit of the normal reference range)
- Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
- Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
- Female who are lactating, pregnant, or planning to become pregnant
- Any clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory test, ECG, ...)
- Use of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to enrolment in this study
- Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
- Subjects not willing to comply with the procedures described in this protocol.
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 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
|
Baseline and 12 weeks
|
|
HbA1c (Glycosylated Hemoglobin)
大体时间：Baseline and 12 weeks
|
Uncontrolled HbA1c>8.5%.
HbA1c and fasting blood glucose taken at hospital
|
Baseline and 12 weeks
|
|
8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate
大体时间：Baseline and 12 weeks
|
8-Iso Prostaglandin F2α (8-iso PGF2α) excretion rate measured during the 24 hours preceding the CGM system removal.
The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Nocturnal), mg/dL
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The nocturnal glycemia measured by CGM system will be defined as the average of glycemic values collected between midnight and breakfast time.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Diurnal), mg/dL
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The diurnal glycemia measured by CGM system will be the average of glycemic values recorded between breakfast time and midnight.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Dawn), mg/dL
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.The glycemia "at dawn" measured by CGM system will be defined as the average of glycemic values recorded between 4 AM and breakfast time.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL
大体时间：Baseline and 12 weeks
|
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
The concentrations of glucose will be assessed from the AUC calculations on glycaemic values measured by CGM system.
|
Baseline and 12 weeks
|
|
Glycaemia According to CGMS (MAGE), mg/dL
大体时间：Baseline and 12 weeks
|
Calculation of the Mean amplitude of glycemic excursion (MAGE) was obtained by measuring the arithmetic mean of the major glucose concentration increases or decreases on days 2 and 3 of glycaemic profile and then averaging results on the two days.
|
Baseline and 12 weeks
|
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
2005年11月1日
初级完成 (实际的)
2007年10月1日
研究完成 (实际的)
2007年10月1日
研究注册日期
首次提交
2006年4月25日
首先提交符合 QC 标准的
2006年4月25日
首次发布 (估计)
2006年4月27日
研究记录更新
最后更新发布 (估计)
2009年5月7日
上次提交的符合 QC 标准的更新
2009年4月10日
最后验证
2009年4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.