NCT00348972已完成1 期
Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Efficacy: 8-point blood glucose measurements.
研究概览
简要总结
To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
- •HbA1c < 7.0%
- •BMI < 40kg/m2
- •Able to perform moderate stationary bicycle exercise
排除标准
- •Chronic pharmacologic treatment for hyperglycemia, past or present
- •serum creatinine > 2.0mg/dL
- •BP > 180/105
- •History of hypoglycemia unawareness
结局指标
主要结局
Efficacy: 8-point blood glucose measurements.
Safety / tolerability: hypoglycemia
次要结局
- Blood glucose in response to exercise.
- Fasting supine levels of counterregulatory hormones
研究者
研究点 (2)
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