KCT0000388已完成未知
Evaluation of efficacy and safety after treatment of twice daily NovoMix30 in patients with type 2 diabetes A multi-centre, open-labelled, single-arm tria (Phase 4)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Type 2 diabetes according to WHO classification.
- •1) Treated with OAD(s) for at three months.
- •2) Age = 18 years.
- •3) Body mass index (BMI) = 25.0 kg/m2.
- •4) Glycosylated hemoglobin (HbA1c) = 7.5 % and = 10.0 % (both inclusive)
排除标准
- •The patients who have history of drug or alcohol abuse, were treated with any other drug known to affect blood glucose (i.e., MAO-inhibitors, beta-adrenergic agents, anabolic steroids, and systemic glucocorticoids), have impaired renal function with serum creatinine = 1.7 mg/dL, have cardiac disease defined as: decompensated heart failure (NYHA classification III and IV), unstable angina pectoris, myocardial infarction within the last 12 months, or severe uncontrolled hypertension (systolic blood pressure when seated > 180 mmHg and/or diastolic blood pressure > 110 mmHg), or have proliferative retinopathy and/or advanced neuropathy as judged by the investigator. Pregnant or breast-feeding, or have the intention to become pregnant.
研究者
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