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The ADA study represents the first randomized head-to-head trial directly compareding an FRC with a remix insulin analog in a population of adults with suboptimally controlled type 2 diabetes on basal insulin plus OADs.
New results from the SoliMix trial show a combination therapy for type 2 diabetes results in a reduction of hypoglycemia rates.
A team, led by Rory J. McCrimmon, assessed the estimated hypoglycemia event rates over the whole treatment period as a function of HbA1c at Week 26 in data presented during the 2021 American Diabetes Association Virtual Meeting.
Premix insulins are commonly used to treat type 2 diabetes patients suboptimally controlled on basal insulin. However, there is an increased risk of hypoglycemia and weight gain.
“Therapeutic approaches to advancing treatment from basal insulin in T2D require assessment of the benefits and risks of any chosen intervention,” the authors wrote.
However, an alternative therapy could be a fixed-ration combination of basal insulin with GLP-1 RA, including iGlarixi (basal insulin glargine 100 U/mL [iGlar] with the GLP-1 RA lixisenatide [Lixi]).
In the 26-week, open-label, multicenter study, the researchers examined 887 adults with type 2 diabetes and HbA1c ≥7.5-≤10.0 % (≥58-≤86 mmol/mol) using basal insulin + metformin ± sodium-glucose co-transporter-2 inhibitors were randomized to once-daily iGlarLixi (fixed-ratio combination of basal insulin glargine 100 U/mL + lixisenatide) or twice-daily premix insulin 30/70 analog (BiAsp 30).
The study represents the first randomized head-to-head trial directly comparing an FRC with a remix insulin analog in a population of adults with suboptimally controlled type 2 diabetes on basal insulin plus OADs.
In the post hoc analysis, the overall study period was 26 weeks, with the titration period being the first 12 weeks and the maintenance period considered weeks 13-26.
The estimated annualized rates—considered the number of hypoglycemic events per participant-year—as a function was derived using a negative binomial model with the total number of hypoglycemic events that occurred from baseline to the conclusion of the interval as the response variable, treatment, and HbA1c at the end of the interval as covariates and log-transformed period duration as an offset variable.
The researchers found both HbA1c improved and bodyweight changes were favorable with iGlarLixi compared to BiAsp 30, which was the predetermined primary outcomes for the study. In addition, hypoglycemia event rates were also lower with iGlarLixi compared to BiAsp 30.
The modelled event profiles for clinically significant hypoglycemia (ADA Level 2 [<54 mg/dL (<3.0 mmol/L)]) were lower with iGlarLixi compared to BiAsp 30. This was true regardless of HbA1c at Week 26, with uncertainty when HbA1c <7.0 % (<53 mmol/mol). There were also only 3 severe—ADA level 3—hypoglycemic events recorded—1 in the iGlarLixi group and 2 in the BiAsp 30 group.
“Lower rates of hypoglycemia with iGlarLixi across a broad range of HbA1c suggests that iGlarLixi facilitates greater HbA1c improvement vs. premix insulin 30/70,” the authors wrote.
The study, “Advancing Therapy in Basal Insulin Users with Type 2 Diabetes (T2D): Hypoglycemia as a Function of HbA1c in the SoliMix Trial,” was published online by ADA.