SoliMix trial supports iGlarLixi for type 2 diabetes
medwireNews: Findings from the SoliMix trial indicate that a fixed-ratio combination (FRC) of basal insulin glargine and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi) may improve glycemic control with weight benefit compared with biphasic insulin aspart (BIAsp) 30 among people with suboptimally controlled type 2 diabetes on basal insulin.
The phase 3b study included 887 obese adults from 17 countries with longstanding type 2 diabetes (average duration 13 years) and glycated hemoglobin (HbA1c) levels of 7.5–10.0% (58–86 mmol/mol) despite treatment with basal insulin and oral antidiabetic agents. Participants were randomly assigned to receive either iGlarLixi once daily or BIAsp 30 twice daily, plus metformin with or without sodium-glucose cotransporter 2 inhibitors for 26 weeks.
Speaking at the virtual 57th EASD Annual Meeting, Rory McCrimmon (University of Dundee, UK) said that compared with BIAsp 30, iGlarLixi was noninferior for HbA1c reduction and superior for bodyweight reduction from baseline to week 26.
Specifically, average HbA1c decreased from 8.6% (70 mmol/mol) at baseline to 7.3% (56 mmol/mol)) at week 26 in the iGlarLixi group, and from 8.6% to 7.5% in the BIAsp group. This corresponded to a least squares (LS) mean difference of 0.2%.
In addition, the presenter said that iGlarLixi-treated people experienced an average bodyweight reduction of 0.7 kg while those receiving BIAsp 30 saw their weight increase by 1.2 kg on average; this corresponded to a significant LS mean difference of 1.9 kg between the groups. He also noted that subsequent hierarchical testing showed that HbA1c reductions were statistically superior with iGlarLixi versus BIAsp 30.
McCrimmon reported that taking iGlarLixi was associated with a reduced risk for ADA level 1 and level 2 hypoglycemia events, at significant odds ratios (ORs) of 0.55 and 0.45, respectively. There were only three ADA level 3 hypoglycemia events, one with iGlarLixi and two with BIAsp 30.
“Safety and tolerability profiles for iGlarLixi and BIAsp 30 were consistent with previous studies,” the presenter said. The most frequently reported adverse events were nausea in the iGlarLixi arm and nasopharyngitis in BIAsp 30 arm.
“These results show that the once-daily FRC, iGlarLixi, is an efficacious and well-tolerated regimen, providing better glycemic control with weight benefit and less hypoglycemia compared with premix BIAsp 30 as an alternative for advancing therapy in people with type 2 diabetes previously suboptimally controlled with basal insulin plus oral antihyperglycemic drugs,” McCrimmon concluded.
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