Toujeo^® vs Tresiba^®—glycemic variability and BRIGHT study results

In a PK/PD study

Lower or comparable within-day variability vs Tresiba

In patients with T1DM, within-day variability was lower or similar for Toujeo than Tresiba, depending on the dose administered.¹

PK/PD data show the time course effect following product administration
These PK/PD data do not support a comparison of the safety and efficacy of Toujeo and Tresiba
Once-daily Toujeo should be injected at the same time each day

Mean glucose infusion rate over 30 hours at 0.4 U/kg

Mean glucose infusion rate over 30 hours at 0.6 U/kg

^*Mean GIR fluctuation (SD):Toujeo 0.38 (0.17) mg/min/kg vs Tresiba 0.46 (0.19) mg/min/kg; treatment ratio 0.80 [90% Cl: 0.66 to 0.96], P=0.047.¹

^†Mean GIR fluctuation (SD): Toujeo 0.45 (0.17) mg/min/kg vs Tresiba 0.48 (0.22) mg/min/kg; treatment ratio 0.96 [90% Cl: 0.83 to 1.11], P=0.603.¹

PK/PD results will vary depending on multiple factors, including, but not limited to, injection site, dose and time of product administration, insulin properties, administration technique, and individualized patient physiologic factors.

Study Design

Randomized, double-blind, two-treatment, crossover euglycemic clamp study to compare the steady-state PK/PD profiles of Toujeo and Tresiba. The study included two cohorts that each evaluated a different dose of once-daily basal insulin (0.4 U/kg/day in cohort 1; 0.6 U/kg/day in cohort 2). AII study participants were adult patients with T1DM and received Toujeo (n=24) or Tresiba (n=24) subcutaneously once-daily before breakfast for 8 days. The insulin dose on Day 8 was given in fasting condition at approximately 8 AM and followed by a 30-hour euglycemic glucose clamp. The clamp was performed to the end of the study or stopped earlier if blood glucose levels exceeded 200 mg/dL for 30 minutes in the absence of an intravenous glucose infusion. Four clamps were excluded from the PD analysis because of insufficient clamp quality. The primary study endpoint was the fluctuation (within-day variability) of the smoothed glucose infusion rate (GIR) over 24 hours in steady state calculated from the area of individual smoothed GIR above and below the individual average GIR line.¹

The first head-to-head, randomized, controlled trial of Toujeo vs Tresiba—A1C results support the EDITION pivotal studies

Primary Endpoint

Powerful A1C reduction at 24 weeks²

Comparable mean change in A1C from baseline to Week 24^2‡§

^‡Baseline: 8.72% ± 0.83% for Toujeo, 8.57% ± 0.80% for Tresiba.²

^§At 24 weeks: 7.03% ± 0.79% for Toujeo, 7.03% ± 0.77% for Tresiba.²

Noninferiority margin of 0.3% and difference between treatments of -0.05% (95% confidence interval -0.15 to 0.05%) at 24 weeks²
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. By Week 24, the mean daily basal insulin dose was 50.47 Units and 39.21 Units for Toujeo and Tresiba, respectively²
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 Tresiba²

Safety Endpoints

Anytime hypoglycemia vs Tresiba over 24 weeks

Incidence and event rate of severe and/or confirmed anytime^¶ hypoglycemia (<54 mg/dL)^2,3

Full Period (Over 24 weeks)^2,3

Titration Phase (Day 1-Week 12)^2,3

Maintenance Phase (Week 13-Week 24)^2,3

P values are for descriptive purposes only and are not adjusted for multiplicity.

^¶Anytime hypoglycemia was defined as hypoglycemia that occurred over 24 hours.

^#Likelihood 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.³

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.

Study Design

A multicenter, open-label, randomized, active-controlled, two-arm, parallel-group, noninferiority study comparing the efficacy and safety of Toujeo and Tresiba U100 in adult insulin-naive 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. The starting doses of Toujeo and Tresiba were 0.2 U/Kg and 10 U once daily, respectively, in accordance with product label and the same insulin titration algorithm was followed. lnvestigational medicinal products (IMPs) were injected in the evening between 6 PM and 8 PM. 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 24.²

The BRIGHT trial results

A video of the first head-to-head, randomized, controlled trial of Toujeo vs Tresiba, covering A1C data and hypoglycemia event rates

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