Posted by Medivizor on Dec 2, 2017 in Diabetes mellitus |
In a nutshell
This study assessed whether patients with uncontrolled diabetes would benefit from adding ertugliflozin to their treatment regime. The authors concluded that ertugliflozin improved blood sugar control among those unable to do so with the combination of metformin (Glucophage) and sitagliptin (Januvia) alone.
Some background
Patients diagnosed with type 2 diabetes (T2D) are usually first advised to follow a healthy diet and exercise plan. Over time, however, medications may be needed. Metformin is usually the first mediciation provided. After this, sitagliptin may be prescribed. Ertugliflozin is a potential third-line therapy. It lowers blood glucose in a different way, and may be useful in combination with the other treatments. The safety and effectiveness of ertugliflozin is still under investigation.
Methods & findings
This study assessed the effectiveness and safety of ertugliflozin in 464 T2D patients. These patients were unable to control their condition with the combination of metformin (greater than 1500 mg/day) and sitagliptin (100 mg/day) alone. Patients received either once-daily 5 mg ertugliflozin, once-daily 15 mg ertugliflozin or a placebo (substance with no active effect). Patients were treated for 26 weeks.
Compared to placebo, the 5 mg treatment reduced HbA1c (average blood glucose levels over 3 months) by 0.7%. The 15 mg treatment reduced levels by 0.8%. A higher proportion of patients treated with ertugliflozin (32.1% to 39.9%) reached an HbA1c level below 7% (compared to only 17% of patients from the placebo group). Those receiving ertugliflozin (either dose) also experienced decreases in fasting blood sugar levels, in body weight and in systolic blood pressure (the measure of the flow of blood as the heart contracts); these measurements were maintained until the end of the study (52 weeks).
There was no difference in hypoglycemia (extremely low blood sugar) or hypovalemia (dehydration) between the treatment and placebo groups. Patients treated with ertugliflozin experienced more fungal infections in the genital area.
The bottom line
This study concluded that adding ertugliflozin to the combination of metformin and sitagliptin may help improve blood sugar control in patients with uncontrolled T2D.
The fine print
This study only assesed the effects of ertugliflozin on patients with no kidney impairment; ertugliflozin may be less effective in patients with kidney impairment. Contrary to the results of this study, ertugliflozin usually causes dehydration; be sure to ask your doctor about this, especially if you are over 65 or are using diuretics.
Published By :
Diabetes, Obesity and Metabolism
Original Title :
Efficacy and safety of the addition of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sitagliptin: the VERTIS SITA2 placebo-controlled randomized study.
