BOSTON — When added to basal insulin, lixisenatide (Lyxumia) is noninferior to rapid-acting insulin for reducing HbA1c and statistically superior to rapid-acting insulin for body weight change, according to a study presented at the American Diabetes Association 75th Scientific Sessions in Boston.
In the study, the use of lixisenatide as a once-daily addition to insulin glargine with or without metformin was compared with the addition of one daily (basal-plus) or three daily injections (basal-bolus) of insulin glulisine with or without metformin.
Lixisenatide is a once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist developed by Sanofi.
The 26-week, randomized, open-label study included adults with type 2 diabetes that were poorly controlled on basal insulin with or without oral antidiabetics for at least 6 months. Patients were randomly assigned to the addition of once-daily lixisenatide to insulin glargine, basal insulin glulisine or basal-bolus insulin glulisine. The co-primary endpoints of the study were reduction in HbA1c and body weight change.
The researchers found that lixisenatide was noninferior to both basal-plus and basal-bolus in reducing HbA1c (LS mean difference, –0.05%; 95% CI, –0.17 to 0.06 vs. basal-plus and 0.21%; 95% CI, 0.10 to 0.33 vs. basal-bolus).
They also found that lixisenatide significantly reduced body weight compared with basal-bolus (LS mean difference, –2.0 kg; 95% CI, –2.6 to –1.4, P<.0001 vs. basal-bolus).
Additionally, the results indicated that lixisenatide significantly reduced postprandial glucose in patients treated before breakfast compared with the other two insulin regimens (LS mean difference, –37 mg/dL; 95% CI, –59 to –15 vs. basal-plus and –40 mg/dL; 95% CI, –61 to –19 vs. basal-bolus).
Rates of hypoglycemia were also lower in patients taking lixisenatide compared with the other treatments (estimated rate ratio=0.8; 95% CI, 0.5-1.1; P=.123 vs. basal-plus and 0.5; 95% CI, 0.3-0.7; P<.0001 vs. basal-bolus).
“There is a need for expanding the options, beyond injectable rapid-acting insulin, to facilitate advancing and further improving basal insulin replacement therapy,” researcher Julio Rosenstock, MD, director of the Dallas Diabetes and Endocrine Center at Medical City, said in a press release.
“This study shows that the addition of lixisenatide to basal insulin was meaningfully effective with some additional benefits over rapid acting insulin.”
Sanofi plans to resubmit lixisenatide to the FDA in the third quarter of 2015.
- Rosenstock J et al. Abstract 107-LB: Advancing Basal Insulin Glargine with Prandial Lixisenatide QD vs. Insulin Glulisine QD or TID in T2DM: The GetGoal-Duo2 Evidence-Based Trial (NCT0768559). Presented at: American Diabetes Association (ADA) 75th Scientific Sessions; June 5-9, 2015; Boston.