Novel Fixed Ratio Combination therapy promising for T2D patients, research shows
Fixed Ratio Combination (FRC) therapy could arise as a valid therapeutic option for the insulin-treated patients that need further intensification, according to a new study.
Type 2 Diabetes (T2D), also called as Adult Onset Diabetes, has emerged as a major global health concern over the past few decades. It is a chronic condition that affects the way the body processes blood sugar (glucose).
With type 2 diabetes, the body either doesn't produce enough insulin, or it resists insulin.
Symptoms include increased thirst, frequent urination, hunger, fatigue and blurred vision. In some cases, there may be no symptoms. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are often prescribed along with metformin for patients with Type 2 Diabetes.
However, approximately 40-60% of people with T2D do not reach their glycemic target, and that resistance to intensification occurs when initiating or titrating basal insulin. To counter this, a team of researchers from Italy, led by Riccardo Candido, proposed the novel approach to treating type 2 diabetes: Fixed Ratio Combination (FRC) therapy.
They evaluated the impact of an FRC, iGlarLixi, in a retrospective, multi-center study, based on electronic medical records. iGlarLixi is a once-daily FRC of basal insulin glargine (100 U/mL) and GLP1-RA lixisenatide. All subjects initiating iGlarLixi in May 2018-July 2020 were analyzed. Overall, 25 centers provided data on 675 subjects between 55-75 years of age. Before starting iGlarLixi, 67.3% of subjects were treated with BI and 9.9% with GLP1-RA. Drugs associated with iGlarLixi were not only metformin and SGLT2 inhibitors, as by summary of product characteristics (SmPC); off-label combinations were found in 32.4% of patients
The results showed:
i) HbA1c decreased by -0.77% [95%CI -1.00;-0.54] after 6 months and by -0.92% [95%CI -1.22;-0.62] in patients treated as by SmPC (Summary of product characteristics).
ii) Weight significantly decreased by 1.21 Kg.
iii) Rates of blood glucose ≤70 and <54 mg/ml (N=171) were 0.26 and 0.05 events per person-month, respectively
iv) No severe hypoglycemic events occurred.
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 concluded.
Reference:
Study titled, "110-LB: 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," as published by American Diabetes Association.
DOI: 10.2337/db21-110-LB
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