REAL WORLD EFFECTIVENESS OF LIXISENATIDE AND OTHER INTENSIFICATION THERAPY IN THE MANAGEMENT OF TYPE 2 DIABETIC PATIENTS UNCONTROLLED WITH BASAL INSULIN.

Background and objectives: Lixisenatide, a selective short-acting glucagon-like peptide 1?receptor agonist (GLP-1RAs), approved in many countries worldwidefor use with oral glucose-lowering agents with or without basal insulin for the treatment of adults with uncontrolled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise. The aim of this study was to assess the effectiveness of basal insulin treatmentregimen intensification with Lixisenatide compared with another injectable drugin patients with T2DM. We also aimed to identify the respective predictive factors for glycemic control. Materials and Methods: This prospective, multi-center, non-controlled observational study included 242 patients with T2DMuncontrolled on their current antidiabetic treatmentwith insulin therapy receiving a GLP-1RAs(122 patients received Lixisenatide and 120 patients received other intensification drugs). The primary endpoints were the change in postprandial glucose (PPG), Fasting plasma glucose (FPG) and HbA1c after three and six months. The patient was considered responder (or at target) if theHbA1c was <7% with nosymptomatic hypoglycemic episode inthe previousthree months and no weight gain since the initiation of intensification therapy. Results: We reported a statistically significant reduction(p<0.001) in HbA1c, FPG,and PPG levels after three and six months on Lixisenatide based treatment. These results did not differ significantly from the other intensification therapy while,a significantdecrease in body weight was observed inLixisenatide group (91.9 to 87.9 kg,p<0.001)compared with other intensification therapy group (83.1 to 82 kg, p=0.605). About 12% of patients in Lixisenatide group and 8.4% of patients in other intensification achieved the target HbA1c <7% after three months of intensification therapy, with no statistically significant differences between the two groups (P=0.26).While after six months of intensification therapy, 36.8% in Lixisenatide group and36.1% in other intensification group achieved thetarget HbA1c <7%, with no statistically significant differences between the two groups (P=0.921). The targeted HbA1c <7% with no symptomatic hypoglycemic episode after three months of intensification therapy and no weight gain was achieved by 11.1% of patients in Lixisenatidegroup compared with 8.4% of patientsin the other intensification therapy group, p=0.26. The safety profile of Lixisenatide, including rates of nausea and vomiting, wasconsistent with that observed in other Lixisenatide therapies. Hypoglycemic events were less in Lixisenatidecompared with other intensification therapy(1.6% versus 6.9%, p=0.03). HbA1c at baseline, regular healthy diet plan,and duration of diabetes were the most significant predictors for the patients? response. Conclusion: The use of Lixisenatide in combination with basal insulin represents an effective and well-tolerable treatment for patients with T2DM, with improvements in glycemic control, reducing body weight or preventing weight gain, with low risk of hypoglycemia.