Toujeo® showed consistent A1C reduction across multiple randomized, controlled trials including EDITION 1-4 and BRIGHT, the first head-to-head trial vs Tresiba®1-6
BRIGHT Study Primary Endpoint:
Toujeo® achieved comparable glycemic control to Tresiba®1
Mean change in A1C from baseline to week 241a,b
a Baseline: 8.72% ± 0.83% for Toujeo®, 8.57% ± 0.80% for Tresiba®.1
b At 24 weeks: 7.03% ± 0.79% for Toujeo®, 7.03% ± 0.77% for Tresiba®.1
Non-inferiority margin of 0.3% and difference between treatments of -0.05% (95% confidence interval—0.15-0.05%).
The mean daily basal insulin dose on Day 1 was higher in the Toujeo® group than in the Tresiba® group: 16.86 Units and 10.15 Units, respectively. By Week 24, the mean daily basal insulin dose was 50.47 Units and 39.21 Units for Toujeo® and Tresiba®, respectively.
Mean (+SD) body weight increased from baseline (90.6+16.1 and 88.7+15.9 kg with Toujeo® and Tresiba®, respectively) to Week 24 (92.5+16.6 and 91.4+16.7 kg), an absolute mean increase of 2.0+3.8 kg with Toujeo® and 2.3+3.6 kg with Tresiba®.
BRIGHT Study Safety Endpoints:
Incidence and event rate of anytimea hypoglycemia1,2
Severe and/or confirmed hypoglycemia (<54 mg/dL)
P values are for descriptive purposes only and are not adjusted for multiplicity.
aAnytime hypoglycemia was defined as hypoglycemia that occurred over 24 hours.
bLikelihood of having a hypoglycemic event.
The most frequently reported treatment-emergent adverse events (TEAEs) (≥5%) were viral upper respiratory tract infection reported in 8.2% in the Toujeo® group and in 8.7% in the Tresiba® group, and upper respiratory tract infection in 5.2% and 4.1%, respectively. Serious TEAEs were 4.5% for Toujeo® vs 4.3% for Tresiba®.
This trial was not designed to evaluate the relative safety of Toujeo® compared with Tresiba®, and comparator adverse event rates are not an adequate basis for comparison of rates between the products.
Hypoglycemia events can vary among studies based on study design, method of collecting data, and hypoglycemia definitions. Hypoglycemia is the most frequently reported adverse event for all insulins; therefore, each patient should be evaluated to determine individual risk and shown how to recognize hypoglycemic signs and symptoms and the actions to be taken should they occur.
A multicenter, open-label, randomized, active-controlled, two-arm, parallel-group, noninferiority study comparing the efficacy and safety of Toujeo® and Tresiba® 100 Units/mL in adult insulin-naïve patients with T2DM not adequately controlled with oral antidiabetic drug(s) ± a GLP-1 receptor agonist. Patients were randomized 1:1 to receive Toujeo® (n=466) or Tresiba® (n=463) subcutaneously between 6 PM and 8 PM over 24 weeks. Doses were adjusted at least weekly, but not more often than every 3 days, targeting a fasting self-monitored plasma glucose (SMPG) of 80-100 mg/dL while avoiding hypoglycemia. The aim of the titration period (Day 1 to Week 12) was the achievement of the fasting SMPG target. The primary endpoint of this study was to demonstrate the noninferiority of Toujeo® to Tresiba® in A1C change from baseline to Week 24.
References: 1. Rosenstock J, Cheng A, Ritzel R, et al. More similarities than differences testing insulin glargine 300 units/mL versus insulin degludec 100 units/mL in insulin-naive type 2 diabetes: the randomized head-to-head Bright trial. Diabetes Care. 2018;doi:10.2337/dc18-0559. 2. Data on file. Clinical Study Report, Sanofi, NCT02738151. 3. Toujeo® Prescribing Information. 4. Riddle MC, Bolli GB, Ziemen M, et al. Diabetes Care. 2014;37(10):2755-2762. 5. Yki-Järvinen H, Bergenstal R, Ziemen M, et al. Diabetes Care. 2014;37(12):3235-3243. 6. Bolli GB, Riddle MC, Bergenstal RM, et al. Diabetes Obes Metab. 2015;17(4):386-394.