Sanofi recently announced that iGlarLixi, the investigational, titratable fixed-ratio combination of insulin glargine 100 Units/ml and GLP-1 receptor agonist lixisenatide, offers greater control of mealtime blood sugar (post-prandial glucose, PPG) in adults living with type 2 diabetes compared to insulin glargine 100 Units/ml alone.
A new post-hoc analysis of data from the LixiLan-L pivotal phase III clinical trial found more patients who received the fixed-ratio combination reached their daily PPG target than those who received only insulin glargine 100 Units/ml. The new analysis was presented at the European Association for the Study of Diabetes (EASD) 52nd Annual Meeting in Munich, Germany. iGlarLixi is currently under review in the United States and Europe.
“Controlling mealtime blood sugar is an important element of maintaining overall blood sugar control, which plays a role in helping patients treat their diabetes,” said Josep Vidal, Hospital Clinic of Barcelona, Barcelona, Spain, and lead author of the study. “This new analysis provides further evidence supporting the use of iGlarLixi by adults with type 2 diabetes who need mealtime blood sugar control alongside greater control of their HbA1c.”
The analysis also showed that a significantly higher proportion of participants reached their PPG target after 30 weeks, according to self-measured plasma glucose (SMPG) taken at intervals throughout the day. As previously reported for LixiLan-L, incidence of symptomatic hypoglycemia was similar with the titratable fixed-ratio combination and insulin glargine 100 Units/ml.
“In the LixiLan-L pivotal phase III clinical trial, investigational iGlarLixi demonstrated superior HbA1c reduction compared with insulin glargine 100 Units/ml alone,” said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi. “With this new analysis, we see further evidence of the role iGlarLixi can serve in helping type 2 diabetes patients meet their PPG targets.”
The presentation abstract is titled ‘Post-Prandial Glycemic Outcomes of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in the LixiLan-L Trial (NCT02058147)’ (Vidal, J et al. Poster presentation 801 – EASD 52nd Annual Meeting in Munich, Germany at 13:15 p.m. CET on September 13).
The post-hoc analysis reviewed data from the LixiLan-L pivotal phase III trial, which compared the effectiveness of the two treatments in 736 adults whose type 2 diabetes was not adequately controlled at screening on insulin glargine alone or combined with one or two oral anti-diabetic agents. The primary outcome of the LixiLan-L study, a statistically significant reduction in HbA1c (average blood glucose over the previous three months) compared with insulin glargine 100 Units/ml, was previously reported at the American Diabetes Association 76th Scientific Sessions, 2016.
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