JPRN-C000000216已完成2 期
Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin. - Efficacy and safety of Metoformin treatment in pediatric patients with Type 2 diabetes.
Establishment of evidences for treatment of pediatric patients with Type 2 diabetes-Particularly optimal doses, effectiveness and safety of treatment with Metoformin study groups.0 个研究点目标入组 50 人开始时间: 2005年9月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 10years-old 至 20years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Previous treatment with insulin within 28 days before screening visit. 2) Known past history of lactic acidosis. 3) Clinically significant renal disease. 4) On hemodialysis. 5) Clinically significant liver disease (ALT, AST > 2 X ULN) . The patient is eligible if elevated ALT and/or AST is due to fatty liver. 6) On shock, cardiac failure, cardiac or pulmonary infarction and have significant chronic cardiovascular, pulmonary insufficiency and hypoxia. 7) On dehydration. 8) With gastrointestinal disorders such as vomiting or diarrhea. 9) On diabetic ketoacidosis or diabetic coma or precoma. 10) On sever infections, surgery or severe trauma. 11) On malnutrition, starvation, collapse and pituitary or adrenal insufficiency. 12) Pregnant or intend to pregnant during treatment period. 13) History of hypersensitivity to biguanides. 14) Complicated with endocrine disorders such as hyperthyroidism, gigantism, Cushing syndrome, growth hormone deficiency or pheochromocytoma. 15) Complicated with or past history of malignant disorders. 16) History of asymptomatic severs hypoglycemia. 17) History of noncompliance with regards to follow-up medical care. 18) The attending physician's judgement of the patient to be inappropriate for the protocol treatment.
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