NCT00384215已完成4 期
Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin: a Randomized, Open, Parallel Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 352
- 试验地点
- 2
- 主要终点
- To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.
研究概览
简要总结
This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.
次要结局
- Compare occurrence of hypoglycemia
- Compare change in body weight
- Compare change in FPG
- Compare change in serum lipid profile
- Compare percentage of subjects achieving HbA1c levels </= 7%
- Compare the time until an HbA1c </= 7% is achieved
- Compare change in HRQOL
- Compare cost of therapy for hyperglycemia treatment
研究者
研究点 (2)
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进行中（未招募）
不适用
Superiority study of insulin glargine over sitagliptin in insulin-naïve patients with type 2 diabetes treated with metformin and not adequately controlled - EASIEType 2 diabetes treated with metformin and not adequately controlledMedDRA version: 9.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlEUCTR2008-000516-32-NLsanofi aventis Groupe530