Merck and Pfizer have reported positive results from the Phase III VERTIS MET and VERTIS SITA clinical trials of ertugliflozin for patients with type 2 diabetes.
Ertugliflozin is an investigational oral SGLT-2 inhibitor currently being developed to improve glycemic control in adult patients.
Both trials are reported to have met the primary endpoint of a statistically significant decrease in A1C when added to metformin or initially administered with sitagliptin.
Pfizer global product development chief development officer James Rusnak said: “These results, combined with findings from other studies in the VERTIS programme, underscore the potential of ertugliflozin as an important therapeutic option for adults with type 2 diabetes to help improve their glycemic control.”
The investigational multi-centre VERTIS MET trial assessed the safety and efficacy of 5mg and 15mg of ertugliflozin combined with metformin over 26 weeks in 621 patients whose disease is uncontrolled on metformin monotherapy.
The trial also showed a significant decrease in body weight, fasting plasma glucose (FPG), diastolic blood pressure (DBP) and systolic blood pressure (SBP).
In the 26-week, randomised, double-blind, investigational, multi-centre VERTIS SITA trial, the efficacy and safety of an initial combination therapy of both doses of ertugliflozin with 100mg of Merck’s DPP-4 inhibitor JANUVIA (sitagliptin) was evaluated in 291 subjects.
In comparison to placebo, the combination indicated a greater decrease in A1C, FPG, body weight and SBP.
The combination therapy in both the trials was reported to have met the secondary endpoint of A1C treatment goal of less than 7%.
The VERTIS clinical development programme of ertugliflozin includes nine Phase III trials in up to 12,600 adults with type 2 diabetes.
Image: Pfizer World Headquarters. Photo: courtesy of Coolcaesar.