Rationale and design of the PIONEER PLUS study evaluating high dose oral GLP-1 receptor agonist therapy for the treatment of type 2 diabetes

Principal Investigator: Vanita Aroda, MD

Authors: Julian L. Moran, Grace Ordonez, Milan Rancic, Natasha Malkani, Lee-Shing Chang, Vanita R. Aroda.
Lay Abstract

Type 2 diabetes is a chronic condition in which the way the body regulates glucose (sugar) is impaired. In addition to lifestyle changes, medications are often required to control blood sugar levels. Inadequate blood sugar control can increase the risk of health problems like heart, kidney, eye and nerve disease. In the U.S., about 50% of patients are not currently at recommended blood sugar treatment goals. Thus, there is interest in evaluating novel therapies that may better help patients achieve treatment goals. The PIONEER PLUS study seeks to evaluate whether higher doses of oral semaglutide are more effective at helping people lower their blood sugar than currently approved doses of oral semaglutide.

 

This randomized study compares three doses of oral semaglutide: 14mg, 25mg and 50mg, daily, over 52 weeks, and aims to enroll 1224 participants at 178 sites globally, including BWH. Change in glucose levels and markers of control (e.g. hemoglobin A1c), body weight, and the achievement of treatment goals will be evaluated.

 

The PIONEER PLUS study will determine how well higher doses of oral semaglutide improve people’s glucose control compared to current standards and whether it can help people achieve their treatment goals and address current gaps in care.

Scientific Abstract

Background: Inadequate glycemic control in type 2 diabetes (T2DM) is associated with an increased risk of health complications. Approximately 50% of patients with T2DM in the U.S. are not currently at recommended treatment goals, in part due to therapeutic inertia.1,2 GLP-1 receptor agonists (GLP-1 RAs) are highly effective medications for T2DM. The PIONEER PLUS study seeks to evaluate the efficacy and safety of higher doses of the first oral GLP-1 RA, oral semaglutide, for the treatment of T2DM.

 

Methods and Results: PIONEER PLUS is a prospective randomized active comparator study evaluating oral semaglutide at final trial doses of 14 mg, 25 mg, or 50 mg daily in patients with poorly controlled T2DM.3 The study is estimated to enroll 1224 participants globally across 178 sites, including BWH. The primary outcome is change in hemoglobin A1c from baseline to week 52, with secondary outcomes including changes in glucose levels, body weight, and achievement of clinical treatment targets.3

Conclusions: The PIONEER PLUS study will determine the extent to which higher doses of oral semaglutide improve glycemic control compared to current standards. Findings will inform whether higher semaglutide doses may help achieve clinical treatment goals, addressing current gaps in care and therapeutic inertia.

Clinical Implications
The PIONEER PLUS trial is studying whether higher investigational doses of oral semaglutide are safe and effective for the treatment of type 2 diabetes. Studying novel therapies may expand treatment choices to support long-term treatment goals for persons with diabetes.

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