904-P: Glycemic Improvement in Patients with Type 2 Diabetes under Treatment with a Fixed-Dose Combination Glimepiride/Vildagliptin/Metformin with Failure to Previous Dual Therapy

Introduction & Objective: Failure to type 2 diabetes (T2D) treatment leads to complications. Combination therapies with different mechanisms of action are often required to achieve glycemic goals. This study aimed to evaluate the efficacy and safety of glimepiride/vildagliptin/metformin in patients with T2D.

Methods: A multicenter, randomized, double-blind study was conducted. Patients over 18 years with previous dual therapy and inadequate glycemic control (glycated hemoglobin (HbA1c) ≥7.0% and ≤11.0%) were included. Participants were initially treated with glimepiride 1/vildagliptin 50/metformin 500 mg. At 45 days, HbA1c was evaluated, patients with efficacy (reduction of HbA1c ≥0.3%) continued with the same treatment, and those with no response were randomly assigned to (2/50/1000 mg) or (4/50/1000 mg). The primary endpoint was efficacy at 90 days.

Results: We enrolled 113 participants (mean age 53 years, HbA1c 9.5 ± 1.0%), three previous therapies were described: Biguanide/Sulfonylurea (62.8%), Biguanide/DPP-4 inhibitors (29.2%) and Biguanide/SGLT2 inhibitors (8.0%). At 45 days, 65.8% of patients showed a positive response, independently of their previous therapy, and 34.2% were escalated. %HbA1c differences were reported: Biguanide/Sulfonylurea (9.5 to 8.7, p=0.001), Biguanide/DPP-4 inhibitors (9.4 to 8.3, p=0.001), and Biguanide/SGLT2 inhibitors (9.3 to 8.6, p=0.040). Over 90 days of follow-up, 107 patients completed the study and 72 achieved a reduction of HbA1c ≥0.3% (63.7%). Three mild hypoglycemic events were reported with the starting dose.

Conclusion: Glimepiride/vildagliptin/metformin therapy improved glycemic control in patients with T2D and previous dual combination failure, this treatment was well tolerated with a low incidence of hypoglycemia.