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A 52-week randomized controlled trial of ipragliflozin or sitagliptin in type 2 diabetes combined with metformin: The N-ISM study

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#Diabetes and Endocrinology 

eMediNexus    29 July 2022

A recent study compared the long‐term efficacy of sodium‐glucose co‐transporter‐2 inhibitors (SGLT-2is) and dipeptidyl peptidase‐4 inhibitors (DPP-4is) in patients with type 2 diabetes (T2D), as second‐line drugs to metformin in individuals with diabetes who are not at a high risk for atherosclerotic cardiovascular disease (ASCVD).

 

The study was a randomized open‐label trial conducted over 52 weeks that compared ipragliflozin and sitagliptin in Japanese, T2D patients without a history of ASCVD who were on metformin.

 

Overall, 111 patients with a mean age of 59.2 years and a mean body mass index (BMI) of 26.6 kg/m2 were selected. Of these, 54 patients were given ipragliflozin, and 57 received sitagliptin. It was observed that after 52 weeks of these therapies, the glycated hemoglobin (HbA1c) reduction (of ≥0.5%) was similar between the two groups.

 

After 24 weeks, the glycated hemoglobin (HbA1c) reduction rate was higher in the sitagliptin group than in the ipragliflozin group. However, between 24-52 weeks, HbA1c reduction with sitagliptin remained subdued; with no significant difference in reductions between the two groups after 52 weeks. However, adverse effects were more frequent with ipragliflozin (17 cases) than with sitagliptin (10 patients).

 

Therefore, it was concluded that sitagliptin renders a greater short-term lowering of HbA1c compared to ipragliflozin, although the HbA1c reduction after 52 weeks of therapy is similar. 

 

The HbA1c‐lowering effect at 24 weeks was greater with sitagliptin than with ipragliflozin. The two drugs showed no difference in efficacy related to HbA1c and body weight at 52 weeks. However, some ASCVD risk factors improved with ipragliflozin. Further, adverse effects were less common with sitagliptin compared to ipragliflozin. 

 

Source: Diabetes, Obesity & Metabolism. 2021 Mar; 23(3): 811–821. 2021. DOI: 10.1111/dom.14288

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