Positive Phase 3 Results for Diabetes Therapeutic

Merck and Pfizer's partnership effort to develop a monotherapy for type 2 diabetes patients is paying off.

According to a study published today in Diabetes, Obesity and Metabolism, phase 3 trial results showed ertugliflozin is safe and effective in treating patients.

The results of the VERTIS Mono trial showd the investigational oral SGLT-2 inhibitor significantly reduced A1C at doses of 5 mg and 15 mg daily.

The data are from the first 26 weeks of a planned 52-week trial.

Both doses showed greater odds of reducing HbA1c to less that 7.0% (53 mmol/mol) compared to placebo. Both doses also significantly lowered fasting plasma glucose, two-hour post-prandial glucose, and body weight.

The placebo-adjusted differences in changes from baseline in systolic blood pressure were not statistically significant.

There was one side effect seen: a higher incidence of genital mycotic inections in both men and women taking the drug.

But there was no significant difference between treaments in the proportion of subjects with symptomatic hypoglycemia or adverse events associated with urinary tract infection or hypovolemia.

The article about the study is entitled, "A Phase 3, Efficacy and Safety Study of Ertugliflozin Monotherapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise Alone."