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

The aim of this study was to evaluate how safe and effective ertugliflozin (Steglatro) is in patients with type 2 diabetes (T2D) that is not controlled well with metformin (Glucophage). The study found that ertugliflozin is safe and improved blood glucose control, body weight, and blood pressure in these patients.

The aim of T2D treatment is to maintain blood glucose control. This can be measured by HbA1c (an average blood glucose level over the past 3 months) levels. When first diagnosed, patients are usually given exercise and diet advice to control blood glucose instead of medication. If blood glucose is not controlled with diet and exercise, patients are normally started on a drug called metformin. If blood glucose is still not controlled with lifestyle advice and metformin, another drug is often added in.

Ertugliflozin is one of the possible drugs that may be added. Ertugliflozin is a SGLT-2 inhibitor. It works by preventing glucose from being taken back up into the body after it is filtered out of the blood in the kidney. Instead, the sugar is removed from the body in the urine. Glimepiride (Amaryl) is another drug that can be added instead of or along with ertugliflozin. It is a sulfonylurea that works by increasing the release of insulin (a hormone that controls blood sugar).

It is not known how safe and effective ertugliflozin is in patients with T2D not controlled well with metformin.

This study was split up into two parts: A and B. Part A consisted of a 26-week treatment with ertugliflozin compared to a placebo (621 participants). After 26 weeks, patients who had not received ertugliflozin and had a fasting glucose of greater than 6.1mmol/L were assigned to receive either glimepiride or a placebo for 78-weeks in Part B (581 participants).

After 104 weeks, patients who received 5mg ertugliflozin had an average decrease in HbA1c of 0.6% and those who received 15mg ertugliflozin had a decrease of 0.9%. 24.6% of patients who received 5mg ertugliflozin and 33.7% of those who got 15mg of ertugliflozin had a HbA1c of less than 7% after 104 weeks. Ertugliflozin also decreased body weight, fasting blood glucose, and blood pressure.

However, there were more female genital infections but lower rates of hypoglycemia (blood glucose going too low) in patients who received ertugliflozin compared to those with placebo/glimepiride.

The authors concluded that ertugliflozin improved HbA1c, fasting blood glucose, body weight and blood pressure in patients with T2D poorly controlled with metformin. The authors also stated that ertugliflozin increased the number of female genital infections but decreased the rate of hypoglycemia.

This study was funded by Merck & Co. and Pfizer Inc., the developers of ertugliflozin.