Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.

ABSTRACT:

Objective

To investigate the efficacy, safety, and tolerability of oral semaglutide added to insulin with or without metformin.

Research design and methods

Patients with type 2 diabetes uncontrolled on insulin with or without metformin were randomized to oral semaglutide 3 mg (N = 184), 7 mg (N = 182), or 14 mg (N = 181) or to placebo (N = 184) in a 52-week, double-blind trial. End points were change from baseline to week 26 in HbA_1c (primary) and body weight (confirmatory secondary). Two estimands were defined: treatment policy (effect regardless of trial product discontinuation or rescue medication) and trial product (effect assuming trial product continuation without rescue medication) in randomized patients.

Results

Oral sema

SUBMITTER: Zinman B 

PROVIDER: S-EPMC7364672 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature