A Multicenter, Prospective, Non-Interventional Evaluation of Efficacy and Safety of Using Biphasic Insulin Aspart as Monotherapy, or in Combination with Oral Hypoglycemic Agent, in the Treatment of Type 2 Diabetic Patients Before, During, & After Ramadan

Moslems with type 2 diabetes who decide to fast during Ramadan may be subjected to metabolic changes which could lead to metabolic complications. The use of premixed insulin analogue (biphasic insulin aspart [BIAsp]) has been recently introduced to allow convenient mealtime dosing without reducing the efficacy of postprandial glycemia control and less risk of developing hypoglycemia. This study was aimed to evaluate the safety and efficacy of BIAsp (NovoMix® 30 FlexPen®, Novo Nordisk A/S, Denmark) in type 2 diabetic patients before, during, and after Ramadan fasting in normal clinical practice. A total of 152 patients were enrolled in this study with slightly more female than male. Patients’ mean age was 54.0 years (22-80 years). There were 65.1% of patients receiving insulin therapy prior to the study entry. Treatment with BIAsp significantly reduced all glycemic indices, i.e. fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2-hr PPG), and glycosilated hemoglobin (HbA1c). There were no significant changes in body weight and BMI. Hypoglycaemic event was almost not found in patients after 3-month of treatment and was significantly reduced compare to baseline events. There were 5 (3.2%) cases of non-serious adverse events during the study. In conclusion, treatment with NovoMix® 30 FlexPen® in type 2 diabetic patients who fast during the Ramadan is effective in maintaining and even in reducing glycemic parameters (FBG, 2-hrPPBG, and HbA1c) as compared to the baseline levels. These improvements were not accompanied with an increase in body weight or body mass index as often found with insulin treatment. The current treatment was also shown to be safe and well tolerated.