Advancing therapy with iGlarLixi safe and effective for diabetes treatment irrespective of SGLT2 inhibitors use: Study
A patient-level pooled analysis of three randomized clinical trials (RCTs) revealed improvement in glycemic status without increased risk of hypoglycemia with iGlarLixi, regardless of concomitant use of SGLT2 inhibitors. The study was published online in Diabetes Research and Clinical Practice on March 4, 2024.
The study showed similar clinically meaningful improvements in HbA1c in both groups. Additionally, fasting glucose, body weight, and post-prandial glucose were similar between groups.
GlarLixi is a titratable fixed-ratio combination of basal insulin glargine 100 units/mL (iGlar) and the short-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA) lixisenatide (Lixi) delivered via a once-daily injection.
Sodium-glucose co-transporter 2 inhibitors (SGLT2is) and GLP-1 receptor agonists with proven cardio- and reno-protective benefits are recommended in patients with type 2 diabetes (T2D) at high risk of cardiovascular disease, heart failure, and chronic kidney disease.
Concomitant use of iGlarLixi and SGLT2 inhibitors has not been well characterized, with only limited evaluation in a small number of patients from a clinical randomized study and a real-world evidence database. The available results showed that iGlarLixi provided glycaemic control with comparably low hypoglycemia rates irrespective of the use of SGLT2is.
Against the above background, Francesco Giorgino, University of Bari Aldo Moro, Bari, Italy, and colleagues aimed to compare the safety and efficacy outcomes of iGlarLixi with or without SGLT2 inhibitors in a pooled analysis.
The post hoc analysis evaluated outcomes in patients who were receiving an SGLT2 inhibitor when initiating iGlarLixi (SGLT2i users) and those who were not (SGLT2i non-users) in a pooled dataset from three trials: SoliMix, LixiLan ONE CAN (advancing from basal insulin), and LixiLan-G (advancing from a GLP-1 RA).
The study led to the following findings:
- Baseline characteristics were generally similar between 219 users and 746 non-users.
- Least squares mean changes in HbA1c from baseline to Week 26 were similar for users (−1.2 %) and non-users (−1.2 %).
- Changes in body weight, fasting glucose, and post-prandial glucose were similar between groups, as were hypoglycaemic events
In conclusion, the pooled analysis of three studies of adults with type 2 diabetes showed that iGlarLixi provides improvements in glycaemic control, irrespective of the use of concomitant SGLT2 inhibitors, with no increase in rates of hypoglycemia.
"Simultaneous use of these therapies may be beneficial to people with T2D with, or who are at risk of, cardiovascular or kidney disease, and/or heart failure, and require cardio- and reno-protective effects alongside improved glycaemic control," the researchers wrote.
Reference:
Giorgino F, Guja C, Aydın H, Lauand F, Melas-Melt L, Rosenstock J. Consistent glycaemic efficacy and safety of concomitant use of iGlarLixi and sodium-glucose co-transporter-2 inhibitor therapy for type 2 diabetes: A patient-level pooled analysis of three randomised clinical trials. Diabetes Res Clin Pract. 2024 Mar;209:111604. doi: 10.1016/j.diabres.2024.111604. Epub 2024 Mar 5. PMID: 38447911.
