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Vascular and metabolic effects of ipragliflozin versus sitagliptin in type 2 diabetes treated with sulfonylurea and metformin: IVS study.

OBJECTIVE: In patients with type 2 diabetes who were inadequately controlled with metformin and sulfonylurea, we compared the glucose-lowering efficacy, cardiometabolic parameters, and safety of two drugs, ipragliflozin, a SGLT-2 inhibitor, and sitagliptin, a DPP-4 inhibitor.

RESEARCH DESIGN AND METHODS: Patients with 7.5%-9.0% glycated hemoglobin (HbA1c) treated with metformin and sulfonylurea were randomly assigned to ipragliflozin (50 mg, n = 70) or sitagliptin (100 mg, n = 70) therapy for 24 weeks. Measures of glycemic control, fatty liver indices, other metabolic parameters, and subclinical atherosclerosis were compared by a paired t-test before and after 24 weeks of treatment.

RESULTS: Mean HbA1c levels decreased from 8.5% to 7.5% in the ipragliflozin group and from 8.5% to 7.8% in the sitagliptin group, resulting in a 0.34% between-group difference (95% confidence interval, 0.10%-0.43%, P = 0.088). Fasting and postprandial 2-hour glucose levels also showed a similar trend, with a greater reduction with ipragliflozin therapy. An increase of over 70% in ketone levels and a decrease in whole body and abdominal fat masses were observed with ipragliflozin treatment. Fatty liver indices also improved with ipragliflozin treatment. Despite no difference in carotid intima-media thickness and ankle-brachial index, ipragliflozin therapy improved flow-mediated vasodilation, reflecting endothelial function, while sitagliptin did not. The safety profile did not differ between the two groups.

CONCLUSIONS: Ipragliflozin add-on therapy can be a viable option for better glycemic control with multiple vascular and metabolic benefits in patients with type 2 diabetes who are inadequately controlled with metformin and sulfonylurea. This article is protected by copyright. All rights reserved.

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