NCT00318656已完成4 期
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.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Duration of Hyperglycaemia (>126 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment
时间窗: Baseline and 12 weeks
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
Episodes of Hyperglycaemia (>126 mg/dL) at Baseline Compared to After 12 Weeks on Treatment
时间窗: Baseline and 12 weeks
Continuous Glycemic Monitoring System, Medtronic (CGMS®) System Gold downloads data to a computer for evaluation of glucose variations.
次要结局
- Duration of Severe Hyperglycaemia (>150 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment(Baseline and 12 weeks)
- Episodes of Severe Hyperglycaemia (>150 mg/dL) at Baseline Compared to After 12 Weeks on Treatment(Baseline and 12 weeks)
- Duration of Hypoglycaemia (<80 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment(Baseline and 12 weeks)
- Episodes of Hypoglycaemia (<80 mg/dL) at Baseline Compared to After 12 Weeks on Treatment(Baseline and 12 weeks)
- Duration of Hypoglycaemia (<60 mg/dL) in Hours at Baseline Compared to After 12 Weeks on Treatment(Baseline and 12 weeks)
- Episodes of Hypoglycaemia (<60 mg/dL) at Baseline Compared to After 12 Weeks on Treatment(Baseline and 12 weeks)
- HbA1c (Glycosylated Hemoglobin)(Baseline and 12 weeks)
- 8-Iso Prostaglandin F2α (8-iso PGF2α) Excretion Rate(Baseline and 12 weeks)
- Glycaemia According to CGMS (Nocturnal), mg/dL(Baseline and 12 weeks)
- Glycaemia According to CGMS (Diurnal), mg/dL(Baseline and 12 weeks)
- Glycaemia According to CGMS (Dawn), mg/dL(Baseline and 12 weeks)
- Glycaemia According to CGMS (Total Area Under the Curve (AUC) for Values Above 1 mg/dL), mg/dL(Baseline and 12 weeks)
- Glycaemia According to CGMS (Postprandial Incremental AUC or Values Above 1 mg/dL), mg/dL(Baseline and 12 weeks)
- Glycaemia According to CGMS (Basal Incremental AUC or Values Above 1 mg/dL), mg/dL(Baseline and 12 weeks)
- Glycaemia According to CGMS (MAGE), mg/dL(Baseline and 12 weeks)
研究者
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