NCT00499707已完成3 期
A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 453
- 试验地点
- 103
- 主要终点
- Change from baseline in hemoglobin A1c (HbA1c) at week 32.
研究概览
简要总结
The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes. The primary objective of the study is to demonstrate superiority of rosiglitazone/metformin compared to its rosiglitazone and metformin.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years of age
- •Clinical diagnosis of type 2 diabetes
- •HbA1c >7.5% to 11%
- •FPG <270mg/dL (15mmol)
- •Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening
排除标准
- •Clinically significant renal or hepatic disease
- •Presence of anemia
- •Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
- •Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment
- •Chronic disease requiring intermittent or chronic treatment with corticosteroids
- •Any female lactating, pregnant, or planning to become pregnant
- •History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
- •Presence of acute or chronic metabolic acidosis
- •History of diabetic ketoacidosis
结局指标
主要结局
Change from baseline in hemoglobin A1c (HbA1c) at week 32.
时间窗: at 32 week
次要结局
- Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks(at 32 weeksInvalid value)
研究者
研究点 (103)
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