Trurapi is formulated as a 100 units/ml solution for injection and is available in cartridges designed to fit the JuniorSTAR and AllStar Pro devices, and as a pre-filled SoloStar pen. It is indicated for the treatment of diabetes in adults, adolescents and children aged 1 year and above.
When injected subcutaneously into the abdominal wall, Trurapi's onset of action occurs within 10 to 20 minutes. The maximum effect is exerted between 1 and 3 hours after injection and the total duration of action is 3 to 5 hours.
Studies have shown Trurapi has a similar pharmacokinetic and pharmacodynamic profile and comparable efficacy, safety and tolerability to NovoRapid.
In a single-dose euglycaemic clamp study in 30 men with type I diabetes, profiles of plasma insulin level and glucose infusion rate over time were similar for Trurapi and NovoRapid, indicating comparable pharmacokinetics and pharmacodynamics.
In a randomised open-label trial in patients with type I or type II diabetes treated with Trurapi or NovoRapid (n=597), HbA1c improved to a similar extent in the two groups over 26 weeks (-0.38% for the Trurapi group vs -0.30% for the NovoRapid group), confirming non-inferiority of Trurapi to NovoRapid. Changes in fasting plasma glucose and seven-point self-monitored plasma glucose profile, including postprandial glucose excursions, and insulin dosages, were also similar in both groups at week 26.
Safety and tolerability, including incidence of hypoglycaemia, was comparable with Trurapi and NovoRapid.