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Eficacitate & Torelabilitate


Edition Program

Studii Toujeo® vs Lantus® la diferite tipuri de populații

 

  • BB, basal-bolus therapy; BOT, basal only therapy; GLP-1, glucagon-like peptide-1; OAD, oral antihyperglycemic drug; SU, sulfonylurea; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus

Referințe

  1. Riddle MC et al; Diabetes Care, 2014;37:2755-62.
  2. Yki-Jarvinen H et al; Diabetes care. 2014;37:3235-43
  3. Bolli GB et al; Diabetes Obes Metab. 2015;17:386-94
  4. Terauchi Y et al; Diabetes, Obesity and Metabolism 18:366-374, 2016
  5. Home PD et al; Diabetes Care,2015 Dec;38(12):2217-25.
  6. Matsuhisa M et al; Diabetes, Obesity and Metabolism 18:375-383, 2016

Design consistent across the program1-6

  • Randomized 1:1, open-label, parallel-group, multicenter studies
  • EDITION program built with similar study design across trials to confirm results
  • Comparator: Lantus®

Non-inferiority to Lantus® in HbA1C reduction at 6 months was the primary endpoint in all trials

Referințe

  1. Riddle MC et al; Diabetes Care, 2014;37:2755-62.
  2. Yki-Jarvinen H et al; Diabetes care. 2014;37:3235-43
  3. Bolli GB et al; Diabetes Obes Metab. 2015;17:386-94
  4. Terauchi Y et al; Diabetes, Obesity and Metabolism 18:366-374, 2016
  5. Home PD et al; Diabetes Care,2015 Dec;38(12):2217-25.
  6. Matsuhisa M et al; Diabetes, Obesity and Metabolism 18:375-383, 2016

Toujeo® provides sustained HbA1c reduction at 1 year compared to Glargine 100

 

Referințe

  1. Steinstrasser A etal. Diabetes obesity Metab.2014: 16;873-6.
  2. Adapted from Becker RH, et al. Diabetes Care.2015

Switching to Toujeo® results in significant less risk of hypoglycemia1

 

*Confirmed ≤ 70 mg/dL (≤ 3,9 mmol/L) or severe hypoglycemic events.

RR: relative risk; T2DM: type 2 diabetes mellitus.

Aim: To compare the efficacy and safety of insulin glargine 300 units/mL with glargine 100 units/mL in people with T2DM using basal insulin ($42 units/day) plus OAD3, a multicenter, open-label, two-arms study. Adults receiving basal insulin randomized to Gla-300 or Gla-100 once Daily for 6 months. The primary end point was change in HbA1c.

Referințe

  1. Adapted from Yki-Jarvinen H et al; Diabetes care. 2014;37:3235-3243

Switching to Toujeo® offers significant less weight gain in patients who required titration1

 

 

Aims: To compare the efficacy and safety of insulin glargine 300 U/ml with glargine 100 U/ml in insulin-naive people with T2DM using OADs, A multicentre, open-label, parallel-group study. Participants were randomized to Gla-300 or Gla-100 once Daily for 6 months, discontinuing Sus and glinides with a dose titration aimed at achieving FPG concentiations 80-100mg/dl. The primary endpoint was change in HbA1c from baseline to month 6.

Referințe

  1. Adapted from Yki-Jarvinen H et al; Diabetes care. 2014;37:3235-3243

RCP Toujeo

 

MAT-RO-2400038 -1.0 – 01/2024