Glycemic control is a clinical goal in the treatment of diabetes mellitus. Currently available bolus insulin analogues do not follow the physiological pattern of insulin secretion after meals because they are slowly absorbed from the injection site. Insulin aspart+nicotinamide is an ultra-fast acting human insulin analog that can be administered before or after meals and the nicotinamide (vitamin B3) molecule provides optimal glycemic control. Aim. To evaluate clinical and economic efficacy of the drug insulin aspart+nicotinamide in comparison with insulin aspart in patients with diabetes mellitus. Materials and Methods. Clinical and economic analysis was performed in accordance with the standards and recommendations valid in the Russian Federation, the method of cost-effectiveness analysis for the first model population of patients with type 1 diabetes and the method of cost-minimization analysis for the second model population of patients with type 2 diabetes, modeling horizon was 26 weeks. Since the study is conducted from the per- spective of the health care system only direct medical costs were considered, that is, the cost of insulin therapy and the cost of complications treatment (hypoglycemia). During the budget impact analysis, the source of data on the target population was the registry of patients with diabetes mellitus of the Russian Federation. Probabilistic sensitivity analysis was performed to assess the impact of changes in the input parameters of the models. Results. Insulin aspart+nicotinamide has a clinical advantage in the effective- ness of HbA1c reduction in type 1 diabetes population. In patients with type 2 diabetes, the effectiveness of insulin aspart+nicotinamide and insulin aspart is comparable by a similar criterion. Direct medical costs of insulin aspart+nicotinamide are 10.64% lower in comparison with insulin aspart use in type 1 and type 2 diabetes patients’ population. The CER value in type 1 diabetes patient population for insulin aspart is 70% higher compared to insulin aspart+nicotinamide (7,410,353.83 and 4,348,513.94 RUR respectively). Budget impact analysis results are the following: that complete replacement of insulin aspart with insulin aspart+nicotinamide over 3 years is accompanied by a 5.3% re- duction of regional drug benefit budget costs. Conclusion. The clinical and economic analysis confirms the economic feasibility of insulin aspart + nicotinamide use