NCT00541437已完成不适用
An Open-Label Study to Investigate the Efficacy and Safety of Type 2 Diabetes Patients Switched From Sulfonylurea With Metformin to Glyburide/Metformin Combination Tablet
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
To evaluate the efficacy and safety of type 2 diabetes patients switched from sulfonylurea co-administered with metformin to glyburide/metformin combination tablet. It is expected that safety and efficacy of GlucoMet® is not inferior to co-administration of sulfonylurea and metformin.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age between 20 to 75 years and were diagnosed with type-2 DM for a minimum of 4 months before baseline.
- •Maintain stable dose of sulfonylurea and metformin co-administered 4 months before baseline.
- •Consider suitable to switch from current therapeutic dose to one of the eight testing regimens.
- •FPG of 80-200mg/dl at screening visit
- •6.5% ≦ HbA1c ≦ 9% at screening visit, and change of HbA1c ≦ 1% within 12 weeks before screening visit.
- •The body index must be between 18.5 and 35 Kg/m2 at screening visit.
- •Sign and date the Informed Consent Form
排除标准
- •Renal disease or renal dysfunction (e.g. serum creatinine > 1.5mg/dl)
- •Currently significant GI disorder (such as peptic ulcer or diarrhea requiring chronic medical treatment) or which may interfere with absorption of the study drugs.
- •History or concurrent liver disease or hepatic impairment (total bilirubin above upper normal limit, ALT or AST above 2.5 times of upper normal limit at screening visit.)
- •Acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis, with or without coma.
- •History of cardiovascular collapse (shock) or congestive heart failure (function class III to IV).
- •History of stroke, myocardial infarction, coronary revascularization, or arrhythmia that requires medical treatment, within past 6 months.
- •Having proliferative retinopathy.
- •Current acute infection, including systemic infection with fever and/or sepsis, or pulmonary infection, cellulitis, etc.
- •Having been treated with insulin during past 6 months, or treated with acarbose or glitazones with change of daily dose past 4 months.
- •Seriously dehydrated.
- •History of alcoholism (all the time or short-term heavy drinking) or drug abuse, or taking other investigational drug.
- •Pregnant or breast feeding women or planning a pregnancy.
- •Having a surgery within 4 weeks prior to entering the study or a history of cancer within five years.
- •Known hypersensitive to glyburide or metformin hydrochloride.
- •Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
研究者
研究点 (1)
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