Oral semaglutide effective in diabetes with renal impairment: PIONEER 5 trial
The pharmaceutical company Novo Nordisk has revealed that based on the results from Phase 3a PIONEER 5 trial, oral semaglutide has hit the mark in the reduction of weight and blood sugar levels in the adult patients with type 2 diabetes (T2D) and moderate renal impairment.
In the PIONEER 5 trial, semaglutide, a once-daily oral GLP-1 analog has achieved its primary objective of demonstrating statistically significant and superior reductions in HbA1c and body weight compared to placebo at week 26.
PIONEER 5 (N=324) was a randomized, double-blind, placebo-controlled, parallel-group, 26-week trial that evaluated the safety and efficacy of oral semaglutide 14mg vs placebo in patients with T2D and moderate renal impairment (eGFR 30 to 59mL/min/1.73m2) inadequately controlled with metformin, sulfonylurea alone or in combination with metformin, or basal insulin alone or in combination with metformin.
According to the primary statistical approach (treatment effect regardless of discontinuation of treatment or initiation of rescue medication), treatment with semaglutide was associated with statistically significantly greater reductions in HbA1c compared with placebo at week 26. In addition, patients treated with oral semaglutide achieved statistically significant and superior reductions in body weight vs placebo at week 26.
Key Results from the Trial:
- When applying the secondary statistical approach, people treated with oral semaglutide experienced a statistically significantly greater reduction in HbA1c of 1.1% compared to 0.1% with placebo.
- Reduction in body weight was statistically significantly greater with oral semaglutide at week 26, with a reduction of 3.7 kg compared to 1.1 kg with placebo.
- From a baseline HbA1cof 8.0%, the proportion of people achieving the American Diabetes Association (ADA) target of HbA1c below 7.0% was statistically significantly greater with 14 mg oral semaglutide, with 64% achieving the target at week 26, compared to 21% with placebo.
- In this 26-week trial, oral semaglutide was well-tolerated in people with moderate renal impairment, with a profile consistent with GLP-1-based therapies.
- The most common adverse event for oral semaglutide was mild to moderate nausea.
- In PIONEER 5, 19% of people treated with oral semaglutide experienced nausea, compared to 8% of people treated with placebo.
- The proportion of people who discontinued treatment due to adverse events was 15% for people treated with oral semaglutide compared to 6% with placebo.
"Renal impairment is a serious diabetes complication and people with this condition have limited oral anti-diabetic treatment options, and if approved oral semaglutide represents an efficacious new solution for these people," stated Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Semaglutide is currently available as a subcutaneous injection for the treatment of type 2 diabetes in adults.