Sanofi announced positive results from the Gel Duo 1 study of it’s investigational GLP-1 agonist, Lyxumia (
lixisenatide) in the treatment of type 2 diabetes patients. The results show that patients with type 2 diabetes uncontrolled on oral anti-diabetics (OADs) – mainly metformin – significantly reduced their HbA1c levels when receiving Lyxumia ( lixisenatide) in combination with Lantus (insulin glargine).
This randomized, double-blind, placebo-controlled study included a 12-week run-in period with insulin glargine initiated and titrated to reach a target fasting plasma glucose of 80-100 mg/dL followed by a 24-week randomized period where 446 patients with HbA1c >7% – despite controlled fasting plasma glucose – received either lixisenatide once-daily or placebo while insulin glargine and metformin were continued. 88% of patients in the lixisenatide arm reached and remained on the 20 ?g maintenance dose.
During the run-in period, HbA1c decreased on average from 8.60% to 7.60%. After randomization the addition of lixisenatide led to a further significantly greater HbA1c decrease compared with placebo (p<0.0001) to a mean value of 6.96% after 24 weeks with a significantly higher percentage of patients achieving target HbA1c <7.0% with lixisenatide vs. placebo (56.3% vs. 38.5%, respectively, p=0.0001). Lixisenatide also significantly improved 2-hour post-prandial glucose with a mean difference of -3.16 mmol/L (p<0.0001) vs placebo. The mean difference in change in body weight between the lixisenatide and placebo groups was -0.89 kg (p=0.0012). Consistent with the GLP-1 class, the most common adverse events were mild and transient nausea and vomiting. Fifty (22.4%) lixisenatide-treated patients and 30 (13.5%) patients in the placebo group reported symptomatic hypoglycemic events as defined in the protocol during the on-treatment period.
The full study results from GetGoal Duo 1 are planned to be presented at a future medical congress.