NCT00174824已完成4 期
Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin
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
- 1,024
- 试验地点
- 2
- 主要终点
- The percentage of patients with a 3-step or greater progression in the patient
研究概览
简要总结
To compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.
详细描述
Randomized, open-label assignment of type 2 patients who are on a stable antidiabetic regimen to treatment with either insulin glargine or BID NPH human insulin, with baseline diabetic retinopathy of severity 53/<53 on the ETDRS scale, for 5 years of followup. Outcomes measured by seven-field fundus photography at baseline, 1.5, 3,6,and 9 months, and annually.
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
- •type 2 diabetes mellitus for at least 1 year
- •treated with oral antidiabetic agents or insulin at stable doses for at least 3 months
- •HbA1c between 6 and 12% inclusive
- •baseline retinopathy severity not to exceed 53/<53 on the ETDRS scale
- •unlikely to require laser surgery or vitrectomy within upcoming year
排除标准
- •prior treatment with insulin glargine
- •treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment
结局指标
主要结局
The percentage of patients with a 3-step or greater progression in the patient
level recoded integer ETDRS retinopathy scale
次要结局
- The percentage of patients who:develop proliferative retinopathy or develop clinically significant macular edema
- the distribution of patients on the patient level recoded integer ETDRS retiopathy scale
- the change from baseline in HbA1c and fasting plasma glucose
- the incidence of hypoglycemia
研究者
研究点 (2)
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