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June 28, 2024TOPLINE:
In patients with type 2 diabetes (T2D) on first-line glucagon-like peptide 1 (GLP-1) receptor agonist therapy, adding or switching to second-generation basal insulins (2BI) may greatly improve A1c and fasting blood glucose (FBG) compared with first-generation basal insulins.
METHODOLOGY:
- As a first-line therapy, GLP-1 therapy may be combined or replaced with first-generation basal insulin or 2BI when it fails to provide adequate glycemic control in T2D; however, the real-world effectiveness of the approaches need to be well understood.
- This prespecified RESTORE-G subgroup analysis included 3164 insulin-naive patients with T2D (A1c levels ≥ 9.0%; median GLP-1 duration of 27.4 months) treated in 32 Italian diabetes clinics.
- Between 2011 and 2021, the patients received basal insulin as either an add-on to (ADD-ON group) or a switch from (SWITCH group) an ongoing GLP-1 therapy.
- Researchers conducted three comparisons between groups with at least 100 patients:
- In the ADD-on cohort, between added first-generation basal insulins (detemir or glargine, 100 units/mL [Gla-100]) and added 2BI (glargine, 300 units/mL [Gla-300] or degludec, 100 units/mL [Deg-100]).
- In the SWITCH cohort, between those switched to the same first-generation basal insulin or 2BI.
- In the SWITCH 2BI group, between those switched to Gla-300 or to Deg-100.
- Propensity score matching was performed, and changes in A1c, FBG levels, and body weight at baseline and at 6 months were assessed.
TAKEAWAY:
- In the ADD-ON cohort, after 6 months, those on 2BI showed greater improvement in A1c (estimated mean difference, −0.32%; P = .04) and FBG levels (estimated mean difference, −20.73 mg/dL; P = .007) than those on first-generation basal insulin.
- In the SWITCH cohort, 2BI led to a 0.22% decrease in A1c (P = .03), a 10.15-mg/dL reduction in FBG (P = .03) levels, and a 0.67-kg decrease in body weight at 6 months (P = .04).
- Among those switched to 2BI, Gla-300 showed a significant improvement over Deg-100, with a 0.89% reduction in A1c levels (P < .001) and a 17.89-mg/dL decrease in FBG levels (P = .02) at 6 months.
IN PRACTICE:
The authors concluded, “The addition of 2BI [second-generation basal insulin] to intensify GLP-1 RA therapy can be considered a valuable therapeutic option to improve metabolic control and prevent weight gain,” further adding that “switching from GLP-1 RA to Gla-300 vs Deg-100 seems to be associated with a greater A1c improvement after 6 months.” They also noted “the urgent need to reduce clinical inertia, as witnessed by the very high A1c levels” at the time of the insulin add-on or switch.
SOURCE:
The study was led by Raffaele Napoli, MD, Department of Translational Medical Sciences, Unit of Precision Internal Medicine, University of Naples Federico II and Institute of Experimental Endocrinology and Oncology, National Research Council, Naples, Italy, and was published online on June 10, 2024, in Diabetes, Obesity and Metabolism.
LIMITATIONS:
The small sample size of the Deg-100 group in the ADD-ON cohort and of the insulin-treated patients in the SWITCH cohort affected the study outcomes. The absence of safety data for subgroup analyses was an additional limitation.
DISCLOSURES:
The study was supported by Sanofi S.r.l., Milan, Italy. Some authors reported serving on advisory board panels, receiving consultancy and speaker’s fees, financial support, or research funding from pharmaceutical or medical device companies including Sanofi. One author reported employment and may hold shares and/or stock options with Sanofi.