NCT00609856已完成4 期
Differences in Metabolic and Cardiovascular Effects of Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes
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
- 36
- 试验地点
- 1
- 主要终点
- Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity
研究概览
简要总结
Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.
详细描述
The present study was undertaken to assess differences in how insulin glargine vs. pioglitazone affect:
- Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test
- Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin resistance (HOMA-IR) and insulin tolerance test and
- Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma lipid profile as add-on therapy in patients with T2D and secondary drug failure. The patients' satisfaction with each treatment was also surveyed.
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
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin
排除标准
- •heart failure (NYHA II-IV)
研究组 & 干预措施
1
Active Comparator
Pioglitazone
干预措施: pioglitazone (Drug)
2
Active Comparator
Insulin glargine
干预措施: insulin glargine (Drug)
结局指标
主要结局
Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity
时间窗: 26 weeks
次要结局
- Effect of pioglitazone vs. insulin glargine on BNP(26 weeks)
研究者
研究点 (1)
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