ISSN 1849-9031 (Online)

ISSN 1849-8922    (Print)

Insulin therapy in patients with type 2 diabetes mellitus: An observational study of everyday medical practice in Serbia, Montenegro and Bulgaria (INSU DM2).
Nebojša M. Lalic, Dragan Micic, Katarina Lalic, Aleksandra Jotic, Plamen Popivanov, Sreten Kavaric.


Objective: The aim of this study was to evaluate the current insulin management of type 2 diabetes (T2D) in the everyday clinical practice and to assess the proportion of patients achieving target glycemic control according to the international recommendations.

Methods: This was an observational, cross-sectional, multicenter, and multinational study that included 1806 T2D patients on long-term insulin treatment from Serbia (940), Bulgaria (666), and Montenegro (200) from February 2011 to December 2012.

Results: Majority of the patients were overweight and obese with mean age 62.4 ± 9.65 years, mean duration of T2D was 13.6 ± 7.9 years, and mean duration of insulin therapy was 6.8 ± 5.5 years. The proportion of patients achieving target hemoglobin A1c (HbA1c) according to the international recommendations was 27.6% (CI: 25.5-29.7). Poor glycemic control defined as HbA1c ≥7.0% was reported in 72.4% of the patients. This cohort was most commonly treated by biphasic insulin regimen in two daily doses (31.6%), or three daily doses (9.5%), basal insulin alone (36.1%), or basal with three prandial doses (16.3%). Basal insulins were used in 56.7% of patients, prandial in 24.8%, and premixes in 45.3% of patients. Insulin type and regimen affected the rate of hypoglycemia: Patients treated with basal analogs and oral antidiabetic drugs had the lowest risk of hypoglycemia.

Conclusions: Achieving good glycemic control in T2D insulin-treated patients in Serbia, Bulgaria, and Montenegro remains a challenge, with a large proportion of patients not reaching recommended glycemic targets. Basal insulins were the most commonly used insulin regimen; however, the use of premixed insulins was much higher compared to other observational studies, performed in Europe. The use of human insulin is high representing 45% of all insulin therapies used. Our findings suggest that inadequate insulin titration is still frequent as well as the risk of hypoglycemia with currently available insulin options and those remain major barrier to optimal insulin therapy and glycemic target achievement in clinical practice.