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Inovație

Toujeo® : A novel insulin glargine formulation

  • Toujeo® forms a smaller subcutaneous depot with ½ surface area compared to Lantus®.

  • This smaller surface area gives Toujeo® more sustained release and flatter profile beyond 24 hours and upto 36 hours1.

  • Toujeo® has the same metabolism (main circulating moiety is M1) as for Lantus®.

This study compared metabolism and metabolite pharmacokinetic (PK) profiles of investigational new insulin glargine U300 (Gla-300) with insulin glargine 100 U/ml in people with type 1 diabetes. Participants received 0.4 (n=18) or 0.6 U/kg Gla-300 (n=12), and 0.4 U/kg Gla-100 (n=30) once Daily in randomized order for 8 days prior to a 36-h euglycaemic clamp.

Referințe

  1. Steinstraesser A et al.Diabetes Obes Metab. 2014;16:873-6.

Toujeo®: A novel insulin glargine formulation

  • Toujeo®  (Glargine 300 U/mL) is a new longer acting insulin Glargine formulation that contains 3-times the amount of insulin glargine per mL.1

  • Toujeo® has the the same amount of units in on third of the volume.


Reduction of volume by 2/3 

 


 

This study compared metabolism and metabolite pharmacokinetic (PK) profiles of investigational new insulin, glargine U 300 (Gla-300) with insulin glargine 100 U/ml in people with type 1 diabetes. Participants received 0.4 (n=18) or 0.6 U/kg Gla-300 (n=12), and 0.4 U/kg Gla-100 (n=30) once Daily in randomized order for 8 days prior to a 36-h euglycaemic clamp.

 

Referințe

  1. Toujeo®SmPC.

50% less glucose fluctuation was seen with Toujeo® vs glargine 100 U/mL1
 

Average glucose profiles evaluated in adults with T1DM with CGM*1

 

Lower within-day fluctuation


vs glargine 100 U/mL Difference between maximum and minimum values: Toujeo®, 14 mg/dL; glargine 100 U/mL, 28 mg/dL

 

Primary endpoint:1

Mean percentage of time in the pre-defined target range (80-140 mg/dL) during the last 2 weeks of treatment:
LSM: 31.8% vs 31.0% for Toujeo® and glargine 100 U/mL, respectively (LSM difference:0.75% [95% Cl: -3.61 to 5.12]:
 

More stable profile and less within-day fluctuation than degludec 100 U/mL1
 

GIR profiles at a 0.4 U/kg/day dose level in steady state in patients with T1DM1

 

Lower within-day fluctuation

vs degludec 100 U/mL1 Treatment ratio (90% CI): 0.80 (0.66 to 0.96): p=0.047

 

 

Primary endpoint: GIR-smFL0-24 was significantly lower with Toujeo® vs degludec 100 U/mL after 8 days.
 

Toujeo® had a more stable and prolonged activity profile vs glargine 100 U/mL*1,2
 

Activity profile at steady state 0.4 U/kg/day*1,2

 

 

Duration of action

 

 

*Result from a single-centre, randomised, double-blind, cross-over study in adults with T1DM (n=18) with euglycaemic clamp technique conducted for maximum of 36 hours after injection. The effect of Toujeo® was beyond 24 hours (up to 36 hours) at clinically relevant doses.1 **GIR determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values). The end of the observation period was 36 hours.2

GIR, glucose infusion rate; glargine 100 U/mL insulin glargine, insulin glargine 100 U/mL; SC, subcutaneous; T1DM, type 1 diabetes mellitus

Referințe

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

DZ2

RCP Toujeo

 

MAT-RO-2400038 -1.0 – 01/2024