Oral Semaglutide Demonstrates Significant HbA1c and Weight Reduction in Phase 3 PIONEER 5 Trial for Type 2 Diabetes Patients with Moderate Renal Impairment

Today, Novo Nordisk announced the results of its Phase 3a clinical trial PIONEER 5, which evaluated the efficacy of oral semaglutide in adult patients with type 2 diabetes and moderate renal impairment.

Diabetes is an increasingly serious global epidemic. As of 2015, 400 million adults worldwide were affected by diabetes, including approximately 100 million in China. Patients with type 2 diabetes either develop insulin resistance or fail to secrete sufficient insulin to maintain normal blood glucose levels. Persistent hyperglycemia can lead to diabetic complications such as heart disease, stroke, kidney failure, neuropathy, lower-limb amputation, and blindness. Therefore, glycemic control is an urgent goal for patients with type 2 diabetes.

Oral semaglutide is an investigational GLP-1 analogue administered once daily as a tablet. This 26-week trial evaluated the efficacy and safety of 14 mg oral semaglutide versus placebo in 324 patients with type 2 diabetes and moderate renal impairment whose disease was inadequately controlled despite treatment with metformin, sulfonylurea monotherapy or in combination with metformin, or basal insulin monotherapy or in combination with metformin.

The PIONEER 5 trial employed two different statistical methods to evaluate the efficacy of oral semaglutide. The first was the primary statistical method required by recent regulatory guidelines, used to assess efficacy regardless of whether patients discontinued treatment or used rescue medication. The second statistical method described efficacy in patients who remained on treatment and did not use rescue medication.

Based on the primary statistical methods, this trial demonstrated that oral semaglutide significantly reduced HbA1c compared with placebo at Week 26, thereby meeting its primary endpoint. At Week 26, oral semaglutide also resulted in a significant reduction in body weight compared with placebo.

When secondary statistical methods were applied, patients in the oral semaglutide treatment group experienced a 1.1% reduction in HbA1c, significantly greater than the 0.1% reduction observed in the placebo group. At week 26, patients in the oral semaglutide group achieved a weight loss of 3.7 kg, significantly greater than the 1.1 kg loss in the placebo group. At week 26, the proportion of patients in the oral semaglutide group who achieved the American Diabetes Association (ADA) HbA1c target (<7.0%) from a baseline HbA1c of 8.0% was 64%, compared with 21% in the placebo group.

Furthermore, in the 26-week study, patients with moderate renal impairment tolerated oral semaglutide well, consistent with the profile of GLP-1 therapies.

“The results of PIONEER 5 demonstrate that oral semaglutide is effective and has a consistent safety profile in patients with type 2 diabetes and moderate renal impairment, thereby further expanding the established clinical profile of oral semaglutide,” said Dr. Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk. “Kidney damage is a serious complication of diabetes, and people with this condition have limited options for oral glucose-lowering therapies. If oral semaglutide is approved, it will provide an effective new solution for these patients.”

We look forward to this effective new glucose-lowering regimen reaching patients in need as soon as possible!

References:

[1] Oral semaglutide provides superior HbA1c and weight reductions versus placebo in people with type 2 diabetes and renal impairment in the PIONEER 5 trial. Retrieved August 20, 2018, from https://www.novonordisk.com/media/news-details.2211959.html

[2] Novo Nordisk. Retrieved August 20, 2018, from https://www.novonordisk.com/

[3] Significant glucose-lowering and weight-loss effects! New diabetes drug announces results from two Phase 3 trials. Retrieved August 20, 2018 from

▽Follow [WuXi AppTecDe】WeChat Official Account