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