Sanofi Aventis Korea has unveiled two phase 3 clinical trial results for Soliqua (insulin glargine and lixisenatide injection), its antidiabetic treatment, at the European Association for the Study of Diabetes (EASD) 2018 Annual Meeting.
The treatment is Korea’s first fixed ratio co-formulation (FRC) antidiabetic therapy.
The trials presented at the conference include LixiLan-L and GetGoal Duo-2.
According to the results of the studies, the combined evaluation variables showed that the average hemoglobin A1c (HbA1c) decreased more significantly in the group treated with Soliqua than in the group treated with a combination of long-term insulin and mealtime insulin.
Nearly 27 percent of patients, who received Soliqua, hit a recommended blood glucose target of less than 7 percent without experiences of hypoglycemic events or weight gain, which was higher than the 12.4 percent of patients treated with the combination treatment.
However, in the clinical trials that provided source data for the analysis, the proportion of patients that experienced gastrointestinal adverse events was higher in patients treated with Soliqua than in patients administered with the combination treatment.
“It is important to understand the impact of various approaches to insulin-enriched therapy on patient outcomes,” said Professor Juris Meier from the Ruhr Universität Bochum St. Josef Hospital and lead author of the researches. “This new analysis used statistical techniques known as propensity score matching (PSM) to reduce potential disturbance factors and allow step-by-step matching of patient data from two separate clinical trials to enable valid comparisons.”
Rachele Berria, Sanofi’s global vice president and head of diabetes medical affairs, also said, “The results of this study demonstrate that Soliqua provides an effective alternative to long-acting insulin and mealtime insulin therapy patients and helps patients reach their glycated hemoglobin target.”
Sanofi will work to ensure Soliqua meets the needs of people with diabetes and extend the clinical relevance of the disease, she added.