How safe and effective is ertugliflozin in patients with poorly controlled type 2 diabetes?

This study determined the safety and effectiveness of ertugliflozin (Steglatro) as a single therapy for adults with poorly controlled type 2 diabetes despite diet and exercise. This study concluded that 1 year of ertugliflozin improved glycemic (blood sugar) control and reduced body weight and blood pressure, but increased genital infections.

Ertugliflozin belongs to a class of drugs that decreases blood sugar levels by preventing the kidneys from reabsorbing it. This type of treatment is the newest oral drug approved for type 2 diabetes. Previous studies have shown that ertugliflozin significantly reduces blood sugar levels. It has also been shown to reduce body weight and blood pressure. Whether ertugliflozin alone also shows these effects in type 2 diabetes patients with poorly controlled blood sugar remains under investigation.

This study involved 461 patients with type 2 diabetes. All patients participated in the first phase (phase A) of the study. 384 patients participated in the second phase (phase B). In phase A, patients received a placebo (substance with no active effect) or one of two doses of ertugliflozin (5 milligrams or 15 milligrams). In phase B, patients continued ertugliflozin or received metformin (Glucophage) instead of placebo. Each phase lasted 26 weeks for a total study period of 52 weeks.

At 26 weeks, patients had HbA1c levels (average blood glucose over 3 months) of 7.3% (15 mg), 7.3% (5 mg), and 7.8% (placebo/metformin group).

At 52 weeks, 28.5% (15 mg) and 25.6% (5 mg) of patients taking ertugliflozin had HbA1c levels less than 7.0%. 27.5% of patients in the placebo/metformin group had HbA1c levels less than 7.0%. 9.9% (15 mg) and 9.0% (5 mg) of patients taking ertugliflozin had HbA1c levels less than 6.5%. 18.3% of patients in the placebo/metformin group had HbA1c levels less than 6.5%.

At 52 weeks, the 15 mg ertugliflozin group showed the most reduction in fasting blood glucose (blood sugar level after not eating for at least 8 hours) and body weight compared to the other two groups. The 5 mg ertugliflozin group showed the most reduction in systolic blood pressure (blood pressure when the heart beats), followed by the placebo/metformin group and the 15 mg ertuglifloxin group.

3.9% (15 mg), 4.5% (5 mg), and 6.5% (placebo/metformin) of patients discontinued study medication due to side effects. 26.9% (5 mg) and 29% (15 mg) of patients taking ertugliflozin reported genital fungal infections compared to 9.9% (placebo/metformin). 10.9% (5 mg) and 6.6% (15 mg) of patients taking ertugliflozin reported urinary tract infections compared to 13.7% (placebo/metformin).

This study concluded that 1 year of ertugliflozin treatment improved glycemic (blood sugar) control and reduced body weight and systolic blood pressure, but increased genital infections.

At the end of the study, more patients in the placebo/metformin group had HbA1c levels less than 6.5% compared to patients in the ertugliflozin groups. This discrepancy may be because patients in the placebo/metformin group had lower baseline HbA1c levels at the beginning of the study.