Efficacy and Safety of Insulin Degludec/Aspart (Ryzodeg) In Type 2 Diabetes Mellitus

Abstract

Background: Type 2 diabetes mellitus (T2DM) is a major global health problem requiring progressive treatment intensification. Insulin degludec/aspart (IDegAsp; Ryzodeg 70/30) is a soluble co-formulation containing 70% ultra-long-acting insulin degludec and 30% rapid-acting insulin aspart, providing basal and prandial glycaemic coverage in a single injection.

Objective: To evaluate the efficacy and safety of insulin degludec/aspart in patients with T2DM.

Methods: This prospective observational study included 170 adults with T2DM who were initiated on or switched to IDegAsp and followed for 24 weeks. Glycaemic parameters, insulin dose, body weight, hypoglycaemia, and adverse events were recorded at baseline, 12 weeks, and 24 weeks. The primary efficacy outcome was change in glycated haemoglobin (HbA1c). Safety outcomes included overall, nocturnal, and severe hypoglycaemia.

Results: The mean age was 54.8 +/- 10.9 years, and 88 patients (51.8%) were male. Mean baseline HbA1c was 9.3 +/- 1.1%, which decreased to 8.1 +/- 0.9% at 12 weeks and 7.5 +/- 0.8% at 24 weeks (p < 0.001). Mean fasting plasma glucose decreased from 181.4 +/- 39.6 mg/dL to 124.8 +/- 28.7 mg/dL, while postprandial plasma glucose decreased from 270.6 +/- 54.2 mg/dL to 174.3 +/- 43.5 mg/dL (p < 0.001). Overall hypoglycaemia occurred in 31 patients (18.2%), nocturnal hypoglycaemia in 8 patients (4.7%), and severe hypoglycaemia in 1 patient (0.6%).

Conclusion: IDegAsp was associated with significant improvement in HbA1c, fasting glucose, and postprandial glucose over 24 weeks, with a low frequency of severe and nocturnal hypoglycaemia. It appears to be an effective and generally safe insulin intensification option for patients with uncontrolled T2DM.