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Evidence

Insulin Trurapi (Insulin aspart 100 units/mL)

Head-to-head studies Trurapi® vs NovoRapid®

Want to know more about the bioequivalence data? Watch this short video summarising the similar PK/PD profile (T1DM), efficacy, safety and tolerability profile (T1DM and T2DM) in Trurapi® vs. NovoRapid® from two clinical studies in adults.1,2

Similar PK/PD profile in adults with T1DM chart

Similar PK/PD profile in adults with T1DM1

PK/PD profiles in the biosimilar Trurapi®, were similar to the UK and EU-approved NovoRapid® and US-approved Novolog® in patients with T1DM.

Download clinical summary

Similar mean HbA1C reduction in adults with T1DM and T2DM chart

Similar mean HbA1C reduction in adults with T1DM and T2DM2

At week 26, HbA1C was -0.38% for Trurapi® group vs -0.30% for NovoRapid®/NovoLog® group. Similar mean HbA1C reduction from baseline to Week 26 in Trurapi® and NovoRapid®/Novolog® groups were observed in patients with either T1DM or T2DM.2

Similar long-term safety and tolerability profiles in adults with T1DM and T2DM chart

Similar long-term safety and tolerability profiles in adults with T1DM and T2DM2,3

Similar incidence rates of any hypoglycaemic events (≥1 event) in both the T1DM and overall population were observed in both Trurapi® and NovoRapid®/Novolog® groups.2,3

For more information and for data from the 6-month safety extension trial, download the clinical summary. 

Download clinical summary

Abbreviations:
EU, European Union; HbA1C, glycated haemoglobin; PD, pharmacodynamic; PK, pharmacokinetic; SE, standard error; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; UK, United Kingdom.

*Mean smoothed body weight standardised glucose infustion rate. This was based on smoothed locally weighted regression in smoothed scattered (LOESS) plots; SAS, PROC LOESS, factor 0.06.1
†Endpoints were analysed in the intent-to-treat population.2
‡Hypoglycaemic data was derived from safety populations.2,3
§Any hypoglycaemia included documented symptomatic hypoglycaemia accompanied by a measured plasma glucose concentration of ≤70 mg/dL (≤3.9 mmol/L) and asymptomatic hypoglycaemia episodes (events not accompanied by typical symptoms of hypoglycaemia but with a measured plasma glucose concentration of ≤70 mg/dL [≤3.9 mmol/L]) were analysed separately and by using a lower more stringent plasma glucose concentration threshold of < 54 mg/dL (3.0 mmol/L).2
**Severe hypoglycaemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.2

References:

  1. Kapitza C, et al. Diabetes Technol Ther. 2020;22(4):278–284.
  2. Garg SK, et al. Diabetes Technol Ther. 2020;22(2):85–95.
  3. Garg SK, et al. Diabetes Technol Ther. 2020;22(2):85–95. (Supplementary Figure S4).
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