The Risk of Severe Hypoglycemia in Patients with Type 2 Diabetes Mellitus Starting Insulin Therapy with Premixed Insulin Analogues Taken Twice Daily: An Observational Study in Turkish Patients

ABSTRACT

Purpose: To assess the risk of severe hypoglycemia in Turkish patients with type 2 diabetes mellitus (T2DM) starting insulin therapy with premixed insulin analogues alone or in combination with oral antihyperglycemic medications.
Material and Method: Data from a subset of Turkish patients who participated in a 1-year, multinational, multicenter, prospective observational study were evaluated. Insulin treatment was initiated using commonly prescribed premixed regimens: insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension) or biphasic insulin aspart 30/70 (30% insulin aspart, 70% insulin aspart protamine suspension) twice daily.
Results: Of the 154 patients treated, 61 (39.6%) were male with a mean age of 56 years and a T2DM duration of 8.9 years. Twelve patients (7.8%) experienced ≥1 episode of severe hypoglycemia, but all recovered. The severe hypoglycemic rate was 0.14 episodes/patient-year. The mean glycated hemoglobin decreased by 2.7% (10.4% to 7.8%) and fasting plasma glucose by 115.9 mg/dL (265.3 mg/dL to 157.6 mg/dL) (p<0.0001). Self-monitored blood glucose (2-hour post morning meal) decreased by 163.3 mg/dL (327.0 mg/dL to 216.2 mg/dL; p<0.0001). Self-monitored blood glucose level was low, particularly at the 2-hour post evening meal. Body mass index increased by 1.4 kg/m2, and total daily insulin dose by 4.2 IU.
Discussion: In Turkish patients with T2DM, initiation of premixed insulin analogues during routine clinical care significantly improves glycemic control during the first year of treatment, but comes with a risk for severe hypoglycemia. Improvements in physician and patient education within the Turkish population regarding hypoglycemia management may be of benefit.