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

Sanofi Aventis Groupe0 个研究点目标入组 520 人开始时间: 2019年9月9日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 468
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 52

•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 screening
•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

发起方