Merck (MSD), together with Pfizer, recently reported that the drug ertugliflozin is able to significantly decrease the average blood glucose levels (assessed as HbA1C) in patients with type 2 diabetes. The findings were obtained from two Phase 3 studies (VERTIS Mono and VERTIS Factorial), and the data were presented at the 76th Scientific Sessions of the American Diabetes Association (ADA) 2016, held in New Orleans.
Ertugliflozin (5 mg and 15 mg daily) is a new, investigational oral SGLT-2 inhibitor agent developed for the treatment of type 2 diabetes. Its efficiency was tested in two clinical trials. The trial VERTIS Mono investigated ertugliflozin as a monotherapy at daily doses of 5 mg and 15 mg for a treatment period of 26 weeks. According to a press release, this study showed that ertugliflozin reduced the average blood glucose by 0.99% (5 mg dose) and 1.16% (15 mg) compared to placebo. Furthermore, an HbA1C of less than 7.0% was achieved by a larger portion of the patients when compared to placebo — 28.2% with 5 mg, 35.8% with 15 mg, and 13.1% for placebo.
The second trial, VERTIS Factorial, with an additional 26-week treatment period, tested the efficacy of ertugliflozin in combination with Merck’s DPP-4 inhibitor Januvia (sitagliptin). This study further demonstrated the efficacy of ertugliflozin combined with sitagliptin in decreasing HbA1C when compared to monotherapies based on ertugliflozin or sitagliptin. Ertugliflozin 5 mg or 15 mg combined with sitagliptin (100 mg) decreased average blood glucose levels by 1.5%, compared to 1.0% obtained with ertugliflozin (5 mg), 1.1% with ertugliflozin (15 mg), or 1.1% with sitagliptin (100 mg).
Researchers also found that a combined ertugliflozin with sitagliptin therapy was more effective in reducing HbA1C to less than 7.0% than ertugliflozin or sitagliptin administrated individually (52.3% with ertugliflozin 5 mg plus sitagliptin 100 mg, and 49.2% with ertugliflozin 15 mg plus sitagliptin 100 mg, compared to 26.4% with ertugliflozin 5 mg, 31.9% with ertugliflozin 15 mg, and 32.8% with sitagliptin 100 mg).
In conclusion, the companies believe that ertugliflozin can be considered an effective therapy for patients with type 2 diabetes.
Diabetes is considered a global epidemic by the World Health Organization due the large portion of the affected population (about 6% worldwide). Type 2 diabetes, characterized by insulin resistance, is the most common type of this disease. While it has no cure, the condition can be managed by marketed drugs.