The study shows a reduction in hemoglobin and a reduced risk of hypoglycemia in participants.
A new study presented at the 2021 American Diabetes Association Virtual Meeting showed the benefits of a fixed-ratio combination (FRC) of basal insulin (BI) in people with type 2 diabetes (T2D).
The study, presented at the event by Riccardo Candido, focused on the efficacy, safety and appropriateness of iGlarLixi, a once-daily FRC. Real-world evidence on FRC iGlarLixi was limited prior to the study, and prompted a 6-month trial among participants with T2D.
The investigators noted that approximately 40-60% of people with T2D worldwide do not reach their glycemic target, and that resistance to intensification occurs when initiating or titrating BI. They believed therapeutic intensification along with FRCs could aid in establishing good diabetes control.
A 6-month trial of iGlarLixi was conducted with 678 subjects culled from 25 different data centers. Over half of the patient population were men (54.2%) with a T2DM duration of roughly 11-15 years.
The participant group was divided into 3 different populations:
Efficacy population (EP) – a subset of the total population that had valid values at baseline and after the 6-month trial
Per-protocol population (PP)- a sample of patients evaluable for the primary end-point who continued treatment after the 6-month trial
Safety population – a sample used for the evalution of severe hypoglycemia
Of the treatments that incorporated iGlarLixi, those who combined the drug with metformin were the most common (54.6%). Patients initiating iGlarLixi were treated using a variety of treatment schemes, and off-label combinations were found in 32.4% of patients.
Finally, participants were divided into two efficacy populations. The EP1 group represented patients with valid values of baselines and after 6 months for the primary endpoint, while the EP2 group was composed of patients with available values of hemoglobin A1C (HbA1C) not treated with short acting insulin and/or other OHA.
Differences in reactions to the iGlarLixi treatment were noted in both efficacy groups.
In EP1, levels of FBG were significantly reduced by 17.74 mg/dl (p=0.001) without significant changes in body weight. More marked improvement were found in FBG in the EP2 group, yet a significant body weight of 1.21 Kg, p=0.002 was also recorded.
When applied in a real-life setting, the study showed that the FRC iGlarLixi was effective in reducing hemoglobin A1C and FBG in participants while also decreasing the risk of hypoglycemia. However, many patients did not discontinue their previous therapies after the 6-month trial.
Investigators attributed this decision to a lack of data in appropriateness and dose intensification, which they hoped would be addressed in future studies.
“iGlarLixi could arise as a valid therapeutic option for the insulin-treated patients that need further intensification, having residual hyperglycemia and/or still lack in titrating basal insulin, based on its effectiveness, reduced risk of hypoglycemia and flexibility of administration,” the team wrote.
The study, “Efficacy, Safety, and Appropriateness of iGlarLixi, a Fixed-Ratio Combination (FRC) in Type 2 Diabetes (T2D) in Real-World Settings: Results from the ENSURE Study”, was published online in ADA.