NL-OMON39048已完成3 期
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-month Safety Extension Period - EDITION I
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with type 2 diabetes mellitus
排除标准
- •- Age <18 years;
- •- HbA1c < 7.0% or >10% at screening;
- •- Diabetes other than type 2 diabetes mellitus;
- •- Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose;
- •- Patients using pre-mix insulins or basal insulins other than insulin glargine or NPH and patients using any non-insulin antihyperglycemic drugs other than metformin in the last 3 months before screening;
- •- Any contraindication to use of insulin glargine as defined in the national product label;
- •- Patients using human regular insulin as mealtime insulin in the last 3 months before screening visit;
- •- Use of an insulin pump in the last 6 months before screening visit;
- •- Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before
- •screening visit;
- •- History or presence of clinical significant macular edema likely to require treatment during the study period;
- •- Most recent eye examination by an opthalmologist>12 months prior randomization visit
- •- Pregnant or breast-feeding women or women who intend to become pregnant during the study period.
- •- Patient who has taken other investigational drugs within 1 month or 5 half-lives, whichever is longer
研究者
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