In a nutshell
This study evaluated the effectiveness of insulin glargine 100U/ml (iGlar; Lantus) and lixisenatide (Lixi; Lyxumia) combined (iGlarLixi; Soliqua) compared with each of the two drugs alone in patients with type 2 diabetes (T2D) that was uncontrolled with 2 anti-diabetic oral drugs. The data showed that iGlarLixi resulted in better glucose control compared to iGlar or Lixi, and did not cause abnormally low blood glucose (hypoglycemia).
Some background
HbA1c levels (average blood glucose over 2 to 3 months) of less than 7% are desirable in patients with T2D receiving metformin (Glucophage) and another oral antidiabetic drug (OAD). Patients that are unable to achieve this target are often given basal (long-acting) insulin such as iGlar. However, some patients may still not achieve a desirable HbA1c level. Also, insulin has the risk of hypoglycemia (dangerously low blood glucose). Therefore, basal insulin therapy may need to be supplemented.
iGlarlixi is a single, daily injection that combines 100 units/mL of iGlar with the short-acting glucagon-like peptide 1 receptor agonist (GLA-1RA), Lixi. iGlarLixi has previously been found to reduce HbA1c levels more effectively in patients treated with metformin with or without a second OAD, compared to iGlar or Lixi. Additionally, compared to iGlar, there is no increased risk of hypoglycemia and weight gain. Further studies are needed in patients with HbA1c levels of 8% and higher, with challenges in achieving HbA1c targets.
Methods & findings
This study included 339 adult patients with T2D and inadequately controlled blood glucose levels. For 4 weeks, patients received metformin with or without a second OAD. After stopping the second OAD, 137 patients received iGlarLixi, 135 patients had iGlar, and 67 patients were given Lixi. Treatments were administered once daily. Changes in HbA1c levels were evaluated for 30 weeks.
After 30 weeks, patients in the iGlarLixi group had significantly higher reductions in HbA1c levels (by 1.9%) compared to iGlar (by 1.6%) or Lixi (by 1%). Also, significantly more patients treated with iGlarLixi reached HbA1c levels below 7% (67%) compared to those treated with iGlar (51%) and Lixi (18%).
Serious side effects occurred in 3.6% of patients in the iGlarLixi group, 5.1% in the iGlar group, and 4.5% of the Lixi group. Symptomatic hypoglycemia occurred in 29% of patients given iGlarLixi, 27.9% that had iGlar, and 12.1% that received Lixi.
The bottom line
The study showed that adult patients with T2D and HbA1c levels of 8% or more after 2 OADs had better glucose control with iGlarLixi than with iGlar or Lixi alone.
The fine print
This study was funded by Sanofi, the manufacturer of iGlarLixi.
Published By :
Diabetes, Obesity and Metabolism
Date :
Oct 06, 2021
