NCT00653341已完成3 期
Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 764
- 试验地点
- 2
- 主要终点
- Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
研究概览
简要总结
The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
- •Body mass index between 26 and 40 kg/m2
- •HbA1c between 7.5% and 10.0%
- •Fasting plasma glucose >7.8 mmol/L and fasting C-peptide > or =0.25 nmol/L
排除标准
- 未提供
结局指标
主要结局
Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
次要结局
- Safety data (Adverse events, vital signs, laboratory values, etc.)
研究者
研究点 (2)
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