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

ABSTRACT:

Aim

To compare the long-term efficacy of sodium-glucose co-transporter-2 inhibitors and dipeptidyl peptidase-4 inhibitors as second-line drugs after metformin for patients not at high risk of atherosclerotic cardiovascular disease (ASCVD).

Materials and methods

In a 52-week randomized open-label trial, we compared ipragliflozin and sitagliptin in Japanese patients diagnosed with type 2 diabetes, without prior ASCVD and treated with metformin. The primary endpoint was a glycated haemoglobin (HbA1c) reduction of ≥0.5% (5.5 mmol/mol) without weight gain at 52 weeks.

Results

Of a total of 111 patients (mean age 59.2 years, mean body mass index [BMI] 26.6 kg/m² , 61.3% men), 54 patients received ipragliflozin and 57 received sitagliptin. After 52 weeks, achievem

SUBMITTER: Kitazawa M 

PROVIDER: S-EPMC7898334 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature