JPRN-jRCTs011180024已完成4 期
Comparison of efficacy of ipraglifrozine and high-dose metformin in patients with type 2 diabetes - COLOR study
Watanabe Taku0 个研究点目标入组 140 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
Regarding glycemic control, improvement was observed in both the ipragliflozin combination group and the metformin double dose group, but no significant difference was observed between the two groups. However, with regard to the antiobesity effect and favorable changes in metabolic parameters, it was suggested that the combination of ipragliflozin may be more effective than increasing the amount of metformin.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- All
入选标准
- •1. age>=20, <75
- •2. HbA1c>=6.5%, <10%
- •3. treated by 500-750 mg/day of metformine in addition to diet and exercise therapy
- •4. no need for additional drug for hypertension or dyslipidemia
- •5. written informed consent obtained
排除标准
- •1. treated by insulin injection
- •2. unstable diabetic retinopathy
- •3. advanced liver, renal or cardiac disease(s)
- •4. allergy to metformine or ipraglyfrozine
- •5. (possible) pregnant or breast-feeding women
- •6. those with severe ketosis or diabetic (pre)coma
- •7. those with severe infection or trauma, or before/after sugery
- •8. those who are inappropriated for the present study
研究者
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