Det kliniske studieprogrammet til Toujeo heter EDITION og består av seks fase III studier på ulike pasientpopulasjoner med type 1-diabetes og type 2-diabetes:
Oversikt over aktuelle publiserte artikler for Toujeo:
- EDITION 1: Riddle MC, Bolli GB, Ziemen M et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care 2014;37:2755–2762.
- EDITION 2: Yki-Järvinen H, Bergenstal R, Ziemen M, et al. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care 2014; 37:3235–3243.
- EDITION 3: Bolli GB, Riddle MC, Bergenstal RM et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015;17:386-94.
- EDITION 1,2 og 3 metaanalyse: Ritzel R, Roussel R og Bolli GB et al. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes. Diabetes, Obesity and Metabolism 2015; 17: 859–867
- EDITION 4: Home PD, Bergenstal RM, Bolli GB et al. New Insulin Glargine 300Units/mL Versus Glargine 100 Units/mL in People With Type 1 Diabetes: A Randomized, Phase 3a, Open-Label Clinical Trial (EDITION 4). Diabetes Care 2015 Dec;38(12):2217-25
- EDITION JP2: Terauchi Y, Koyama M, Cheng X et al. Glycaemic control and hypoglycaemia with insulin glargine 300 U/mL compared with glargine 100 U/mL in Japanese adults with type 2 diabetes using basal insulin plus oral anti-hyperglycaemic drugs (EDITION JP 2 randomised 12-month trial including 6-month extension)Diabetes Metab. Oct;43(5):446-452
- EDITION JP1: Matsuhisa M, Koyama M, CHeng X et al. New insulin glargine 300 U/mL versus 100 U/mL in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a randomized controlled trial (EDITION JP 1) Diabetes Obes Metab. 2016 Apr;18(4):375-83
- PK/PD studie: Becker RHA,, Dahmen R, Bergmann K et al. New Insulin Glargine 300 Units•mL-1 Provides a More Even Activity Profile and Prolonged Glycemic Control at Steady State Compared With Insulin Glargine 100 Units•mL-1. Diabetes Care 2015;38:637–64.
SANO.TJO.17.10.0314