Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)

This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.

本试验在全球范围内开展。本试验旨在探究口服司美格鲁肽（oral semaglutide）对比安慰剂，在接受胰岛素治疗的2型糖尿病（Type 2 Diabetes Mellitus）受试者中的疗效与安全性。所有受试者需在整个试验期间维持试验前的胰岛素治疗方案，包括基础胰岛素、基础-餐时胰岛素或预混胰岛素方案（含可溶性胰岛素联合方案）。同时接受二甲双胍（metformin）联合胰岛素治疗的受试者，需在整个试验期间维持二甲双胍治疗。