Insulin Analogues (NovoMix® 30 FlexPen®, or Levemir® FlexPen®, and/or NovoRapid® Flex Pen®) in the management of diabetes mellitus in the Gulf Countries

Abstract

Evaluation of safety and efficacy of insulin aspart (NovoRapid® FlexPen®), insulin detemir (Levemir® FlexPen®), biphasic insulin aspart 30 (NovoMix® 30 FlexPen®), and their combination for the treatment of type 1 and type 2 diabetes in the Gulf countries in a prospective, multicenter, open label, non-interventional, observational study. A total of 5,866 patients with type 1 or type 2 diabetes were followed for 6 months. The primary efficacy endpoint was the change in glycoslyated hemoglobin (HbA1c) from baseline, while the secondary efficacy endpoints were the percentage of patients achieving HbA1c less than 7.0% approximately 12 and 24 weeks compared to baseline and changes in fasting blood sugar and postprandial blood sugar after 12 and 24 weeks of treatment compared to baseline. The primary safety endpoint was the incidence of major hypoglycemic episodes during the 24 weeks of using the study medication, while the secondary safety endpoints were changes in the number of hypoglycemic episodes in the past 4 weeks prior to the routine visits at approximately 12 and 24 weeks of treatment. The reduction in glycemic control measured by mean HbA1c from baseline to after 6 months was 2.4 (from 9.8 to 7.4, p-value < 0.0001) in all treatment groups after 24 weeks irrespective of the previous insulin regimen. The change in HbA1c after 24 weeks of treatment was 2.4 % in the Levemir® group, -2.3% in the NovoMix®30 group, 2.5% in the NovoRapid® group, 2.3 % in the combination group. The proportion of patients who achieved the target HbA1c increased from 1.7% at baseline to 26.9% after 24 weeks of treatment with insulin analogues. The change in the mean body weight after 24 weeks of treatment was 1.3 kg in the Levemir® group, 0.9 kg in the NovoMix®30 group, 0.1kg in the NovoRapid® group, and 0.7kg in the combination group. The change in major hypoglycemia was as follows: In the detemir group 2.9% at baseline to 0.2% at week 24, in the BIAsp30 group was 2.9% at baseline to 0.2% at week 24, in the aspart group 3.1% at baseline to 0% at week 24 (p < 0.0001).Switching to insulin Aspart (NovoRapid® FlexPen®), insulin detemir (Levemir® FlexPen®), biphasic insulin aspart 30 (NovoMix® 30 FlexPen®), or the combination of any of them resulted in significant lowering in HbA1c, fasting blood sugar, postprandial blood sugar, postprandial glucose increment, and the number of major hypoglycemic attacks. The percentage of patients attaining the required HbA1c below 7% was 26.9%. The body weight was reduced in all treatment groups.