Efficacy and Safety of Insulin Degludec/ Insulin Aspart (Ryzodeg) in Patients with Type 2 Diabetes Mellitus: A Prospective Clinical Study

Abstract

Background: Type 2 diabetes mellitus is a progressive metabolic disorder characterized by chronic hyperglycemia, insulin resistance, and progressive pancreatic beta-cell dysfunction. Insulin degludec/insulin aspart (IDegAsp), marketed as Ryzodeg, is a soluble co-formulation containing 70% ultra-long-acting insulin degludec and 30% rapid-acting insulin aspart. It provides basal and prandial insulin coverage in a single injection and may offer a convenient approach to insulin intensification.

Objective: To evaluate the efficacy and safety of insulin degludec/insulin aspart in patients with type 2 diabetes mellitus by assessing glycemic control, fasting plasma glucose, postprandial glucose, hypoglycemia, body weight, and treatment-related adverse events.

Methods: This proposed prospective observational study involved 240 adults with inadequately controlled T2DM who initiated IDegAsp as part of routine clinical management. Glycemic parameters were assessed at baseline, 12 weeks, and 24 weeks. The primary outcome was change in glycated hemoglobin (HbA1c) from baseline to 24 weeks. Secondary outcomes included fasting plasma glucose (FPG), postprandial plasma glucose (PPG), achievement of HbA1c below 7%, changes in body weight, hypoglycemic episodes, and adverse events. Data were analyzed using appropriate repeated-measures methods and descriptive statistics.

Results: Mean HbA1c decreased from 9.2 ± 1.3% at baseline to 7.9 ± 1.1% at 12 weeks and 7.3 ± 0.9% at 24 weeks, representing a mean reduction of 1.9 percentage points. Mean FPG decreased from 186.4 ± 42.6 mg/dL to 128.6 ± 27.4 mg/dL, while mean PPG decreased from 264.8 ± 54.2 mg/dL to 176.3 ± 38.5 mg/dL. At 24 weeks, 108 (45.0%) patients achieved HbA1c below 7%. Symptomatic hypoglycemia was reported in 34 (14.2%) patients, nocturnal hypoglycemia in 11 (4.6%), and severe hypoglycemia in 3 (1.3%). Mean body weight increased by 0.8 kg.

Conclusion: The findings illustrate clinically meaningful improvement in glycemic parameters over 24 weeks following initiation of IDegAsp, accompanied by hypoglycemic events and modest weight gain.