NCT03910361已完成4 期
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 7
- 主要终点
- Changes from baseline intrahepatic fat (%)
研究概览
简要总结
A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and non-alcoholic fatty liver diseases
详细描述
- Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks
- Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II diabetes mellitus
- •Subjects who have not been taking any oral hypoglycemic agent within 8 weeks from screening or who have been taking metformin monotherapy at the same dose for more than 8 weeks before screening
- •Subjects with 6.5%≤HbA1c≤9.0% at screening
- •Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
排除标准
- •Type I diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- •AST > upper normal range*3
- •Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Subjects who experienced hypersensitivity reaction against DPP-4 inhibitors, thiazolidinediones
- •Pregnant women
研究组 & 干预措施
Evogliptin
Experimental
evogliptin 5mg
干预措施: Evogliptin (Drug)
Pioglitazone
Active Comparator
pioglitazone 15mg
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Changes from baseline intrahepatic fat (%)
时间窗: 24 weeks
Changes from baseline intrahepatic fat (%) after treatment with evogliptin or pioglitazone
次要结局
未报告次要终点
研究者
研究点 (7)
Loading locations...
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