TRELAGLIPTIN'S REAL WORLD EFFICACY AMONG TYPE 2 DIABETES PATIENTS IN CAMBODIA (TRELA -REAL STUDY)

Abstract

Background: Trelagliptin is the rst once-weekly oral therapy for type 2 diabetes in Cambodia. The afrmation of its efcacy and safety in Cambodian Type 2 Diabetes patients is to be established for extending the clinical benet of this unique oral anti-diabetic agent in this population Objective: To conrm the effect of Trelagliptin (TRELA), a selective once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor, on glycemic control in the management of Type 2 Diabetes Mellitus (T2DM) in real-world practice settings in Cambodia Methods: An open-label, multicentric prospective, observational single-arm study was conducted across Phnom Penh and three other provinces in Cambodia which will include Siem Reap, Kampong Cham, and Battambang in outpatient settings. One hundred and fty patients with Type 2 Diabetes were enrolled after seeking informed consent. Trelagliptin 100 mg one tablet per week was administered to patients with type 2 diabetes who showed poor glycemic control (HbA1c ≥6.5% ) on diet/exercise therapy alone or diet/exercise therapy plus other oral antidiabetic agents or insulin. The study primary endpoint(s) included changes in glycated hemoglobin (HbA1c) from baseline at the end of three months, and at the end of six months of the study. The secondary endpoints included patient satisfaction and investigator assessment at the end of treatment (6 months) to once weekly treatment to Trelagliptin. Result: Treatment with Trelagliptin 100 mg/week led to a mean change in HbA1c 0.86% (from 8.76 ± 2.02 to 7.9 ± 1.60, p < 0.05, CI 95) at the end of 3 months. At the end of 6 months, the mean change in HbA1c was 1.26% (from 8.76 ± 2.02 to 7.5 ± 1.34), p<0.05, CI 95) (p-value signicant) Patient satisfaction and preference with once-weekly trelagliptin treatment was reported in 97.04 % (n=131) patients. As per the investigator's assessment, 77.04 % (n=104) of the patients reported a “good” response to Trelagliptin treatment at the end of the study over a period of 6 months. In 14.07 % (n=19) patients investigators reported that “excellent” response was achieved. Whereas 5.19% (n=7) and 3.7% (n=5) patients reported average and poor responses, respectively. Trelagliptin treatment once a week was demonstrated to be clinically efcacious as monotherapy and in combination with other anti-hyperglycemic agents. Trelagliptin treatment was found to be efcacious in treatment naïve and treatment-experienced patients. The clinical benets of Trelagliptin were consistent across age groups, body mass index (BMIs), and associated co-morbidities like hypertension. Trelagliptin was well tolerated and was safely used in addition to Metformin, Sulfonylureas, Thiazolidinediones, SGLT2-inhibitors & Insulin treatment. The glucose-lowering effect of Trelagliptin was comparable to other DPP4 inhibitors (gliptins), and other classes of oral anti-diabetic medications with the additional advantage of once-a-week dosing treatment regime. Conclusion: Treatment with once-a-week trelagliptin as initial monotherapy and in combination therapy with other anti-hyperglycemic agents for glucose control in Type 2 Diabetes was efcacious and well-tolerated. Trelagliptin 100 mg once a week treatment achieved treatment satisfaction in most patients and reported “good” investigator response in majority of type 2 diabetes patients. Trelagliptin 100 mg once-a-week treatment is a useful consideration in the management of type 2 diabetes patients