Three trials from the QWINT global phase 3 clinical trial programme has found that the once-weekly basal insulin analog efsitora alfa lowers HbA1c as effectively as daily basal insulins in people with Type 2 diabetes (T2D) who require insulin.
The QWINT-1 trial compared the efficacy and safety of a fixed-dose regimen of efsitora with once-daily glargine for 52 weeks in insulin-naive people with T2D; QWINT-3 compared efsitora with daily degludec for 78 weeks in adults already taking basal insulin; while QWINT-4 compared efsitora with daily glargine for 26 weeks in adults with T2D taking both basal and pre-meal bolus insulin.
QWINT-1 was an open-label trial of 795 adults with T2D who had not previously taken insulin. Participants were randomized to weekly efsitora delivered by a single-use auto-injector or daily injected insulin glargine. Efsitora was titrated to four fixed doses at 4-week intervals, as needed for blood glucose control. At week 52, efsitora had reduced HbA1c from 8.20% to 7.05%, compared with 8.28% to 7.08% with glargine. In addition, the rate of combined clinically significant and severe hypoglycaemia was significantly lower with efsitora than glargine.
In QWINT-3, 986 adults with T2D who had already been treated with basal insulin and other noninsulin glucose-lowering medications, were randomized 2:1 to weekly efsitora or daily degludec. At week 26, HbA1c had decreased by 0.81 percentage points with efsitora versus 0.72 with degludec. However, level 1 (mild) hypoglycaemia was significantly more common with efsitora.
In QWINT-4, 730 participants with T2D who had been treated with both basal and prandial insulin and up to three noninsulin glucose-lowering agents were randomized to efsitora or glargine U100, both with premeal insulin lispro. At 26 weeks, mean HbA1c was 7.17% in the efsitora group and 7.18% in the glargine group. As in QWINT-3, mild hypoglycaemia was more common with efsitora.
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