NL-OMON48426已完成4 期
A 12-week randomized, controlled trial to compare TOUJEO® and TRESIBA® in terms of glucose values in target range and variability during continuous glucose monitoring in patients with type 1 diabetes mellitus - inRange
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
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
- •Participants with Type 1 Diabetes mellitus (T1DM)
- •Participants treated with multiple daily injections (MDI) using basal insulin
- •analog once daily and rapid acting insulin analogs for at least one year
- •HbA1c * 7% (48 mmol/mol) and * 10% (86 mmol/mol) at screening
排除标准
- •Participants not on stable dose of basal insulin analog
- •Participants having received Toujeo or Tresiba as basal insulin within 30 days
- •prior to screening
- •Participants not using the same insulins (both basal and rapid) within 30 days
- •prior to screening
- •Participants having received basal insulin dose *0.6 U/kg body weight within 30
- •days prior to screening
- •Participants having received any glucose lowering drugs (including any premixed
- •insulins,human regular insulin as mealtime insulins, any others injectable or
- •oral), other than basal and rapid insulin analogs, within 3 months prior to
- •End stage renal disease or on renal replacement treatment
- •Retinopathy or maculopathy with one of the following treatments, either recent
- •(within 3 months prior to screening) or planned: intravitreal injections or
- •laser or vitrectomy surgery
- •Body weight change *5 kg within 3 months prior to screening
研究者
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