Toujeo^® U-300 (insulin glargine) injection 300 Units/mL vs Tresiba^®

*Baseline: 8.72% ± 0.83% for Toujeo, 8.57% ± 0.80% for Tresiba.^1
†At 24 weeks: 7.03% ± 0.79% for Toujeo, 7.03% ± 0.77% for Tresiba.¹

BRIGHT study Toujeo vs Tresiba: Primary endpoint achieved

• Noninferiority margin of 0.3% and difference between treatments of -0.05% (95% confidence interval -0.15 to 0.05) at 24 weeks¹

• 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, 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 kg 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 Tresiba¹

The most frequently reported 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.^1,2

• 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 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 how to recognize hypoglycemic signs and symptoms and the actions to be taken should they occur³

Hypoglycemia

(Events per patient year over 24 weeks)^1‡

 P values are for descriptive purposes only and are not adjusted for multiplicity.
Event rates during Maintenance Phase were comparable.

Incidence of severe and/or confirmed hypoglycemia was 7.8% for Toujeo (n=36) vs 11.7% for Tresiba (n=54) in the Titration Phase.²

Incidence of severe and/or confirmed hypoglycemia (<54 mg/dL) for Toujeo was 14.7% (n=68) and 18.4% for Tresiba (n=85).²

Incidence of severe and/or confirmed hypoglycemia was 9.8% for Toujeo (n=44) vs 11.2% for Tresiba (n=50) in the Maintenance Phase.²

^‡Anytime severe and/or confirmed hypoglycemia (<54 mg/dL).¹

Hypoglycemia is the most common adverse event associated with insulin-containing therapies.

BRIGHT renal subgroup data: Greater A1C reduction observed with Toujeo in patients with renal insufficiency^6,7

Renal function subgroups (eGFR ≥90 [normal], 60 to <90 [mild] and <60 mL/min/1.73 m² [moderate/severe])⁷

A1C reduction was consistent with the BRIGHT primary endpoint⁷

Comparable risk of hypoglycemia⁷

BRIGHT study Toujeo vs Tresiba: Subgroup analysis⁷

This exploratory subgroup analysis was not designed or powered to detect differences between treatment groups.

Anytime (24h) confirmed (≤70 mg/dL) hypoglycemia events per patient year:

• Toujeo 6.5 vs Tresiba 10.5 (≥90 mL/min/1.73 m²)
• Toujeo 12.3 vs Tresiba 10.5 (60 to <90 mL/min/1.73 m²)
• Toujeo 13.5 vs Tresiba 13.9 (<60 mL/min/1.73 m²)
   

This exploratory subgroup analysis was not designed or powered to detect differences between treatment groups. The effect of renal impairment on the PK of Toujeo has not been studied. Frequent glucose monitoring and dose adjustment may be necessary.³

Hypoglycemia is the most common adverse event associated with insulin-containing therapies
Primary endpoint: LSM difference 3.16% (95% CI: 0.88, 5.44), P=0.0067^5¶

• A hierarchical step-down testing procedure was applied to the primary efficacy endpoint and main secondary endpoints: noninferiority for glucose total coefficient of variation, and superiority for percentage TIR, to control for type I error. Superiority of Toujeo with respect to Tresiba was not demonstrated on the primary efficacy endpoint (LSM difference, -2.35% [-4.75 to 0.05]; P=0.0548)^5,10

^llAny documented or severe hypoglycemia.^5,10
¶Noninferiority was assessed in the intent-to-treat population. Noninferiority of the primary endpoint was demonstrated if the lower bound of the two-sided 95% CI of the adjusted difference estimate for m1–0.9 m0 (where m1 and m0 are the true means for Toujeo and Tresiba groups, respectively) was greater than 0.^10
#Time below range is defined as % time people spent <70 mg/dL.⁵