NCT00241605已完成4 期
AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 92
- 主要终点
- Change from baseline in HbA1c at week 48.
研究概览
简要总结
This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
- •Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
- •Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
排除标准
- •Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
- •Have a known hypersensitivity to thiazolidinediones or biguanides.
- •Currently using insulin or any oral anti-diabetic agent other than metformin.
- •History of metabolic acidosis.
- •History of substance abuse.
- •Have active cancer other than localized squamous or basal cell carcinoma.
- •Chronic disease requiring treatment with corticosteroids.
- •Other criteria will be evaluated at the screening visit.
结局指标
主要结局
Change from baseline in HbA1c at week 48.
次要结局
- Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.
研究者
研究点 (92)
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