Positive Phase III Data for Novo’s Diabetes Drug

Eli Lilly’s diabetes drug Trulicity may soon have some competition.

Novo Nordisk announced on Wednesday its investigational diabetes drug met the main goal of reducing glucose levels in patients in its Phase III trial.

The head-to-head comparison pitted Novo’s semaglutide against Lilly’s dulaglutide (Trulicity). The SUSTAIN 7 trial results demonstrated that people with type 2 diabetes treated with once-weekly semaglutide experienced superior reduction in HbA1c and body weight compared to treatment with dulaglutide. The study enrolled about 1,200 patients with type 2 diabetes.

The 40-week trial investigated the efficacy and safety of two doses of the diabetes drug: 0.5 mg semaglutide compared with 0.75 dulaglutide and 1.0 mg semaglutide compared with 1.5 mg dulaglutide, when added to metformin.

From a mean baseline HbA1c of 8.2 percent, patients receiving 0.5 mg of semaglutide achieved a statistically significant reduction of 1.5 percent compared to 1.1 percent for 0.75 mg of dulaglutide.

Patients treated with 1.0 mg of semaglutide experienced a statistically significant reduction of 1.8 percent versus 1.4 percent for 1.5 mg of dulaglutide.

Meeting target HbA1c

Sixty-nine percent of patients treated with 0.5 mg semaglutide achieved the Americana Diabetes Association (ADA) treatment target of HbA1c below or equal to 7.0 percent, compared to 52 percent of those treated with 0.75 mg dulaglutide.

In the 1.0 mg semaglutide group, 79 percent of patients compared to 68 percent of the patients with 1.5 mg dulaglutide reached the ADA treatment goal.

Positive results were also seen using the American Association of Clinical Endocrinologists (AACE) treatment target of HbA1c below or equal to 6.5 percent.

Fifty-one percent of people treated with 0.5 mg semaglutide compared with 36 percent of people treated with 0.75 mg dulaglutide reached the treatment goal, and 68 percent of people treated with 1.0 mg semaglutide compared to 49 percent with 1.5 mg dulaglutide reached the treatment goal.

Statistically significant weight loss

The average weight loss for the two doses of semaglutide were at least twice as high compared to dulaglutide. Patients treated with 0.5 mg and 1.0 mg of semaglutide experienced mean weight loss of 4.6 kg and 6.5 kg, respectively; while patients receiving 0.75 mg and 1.5 mg of dulaglutide lost an average of 2.3 kg and 3.0 kg, respectively.

Also, the number of patients reporting an adverse event of diabetic retinopathy was low and comparable in both the arms, according to the company.

“The superior glucose control and weight loss achieved with semaglutide compared to dulaglutide in this trial reinforces the unprecedented results observed in the entire SUSTAIN programme,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk in a company statement. “We are excited about the potential of semaglutide to set a new standard for treatment of type 2 diabetes”.

Semaglutide is currently under review at the FDA and EMA.