Fotagliptin add-on therapy to metformin in patients with uncontrolled type 2 diabetes: A randomised, multicentre, double-blind, placebo-controlled, phase 3 trial.

ABSTRACT:

Aim

Fotagliptin is a novel dipeptidyl peptidase-4 inhibitor for glycaemic control in patients with type 2 diabetes (T2D). This trial aimed to assess the efficacy and safety of fotagliptin add-on to metformin in patients with T2D.

Materials and methods

In this phase 3 randomised, double-blind, placebo-controlled study, patients with T2D who had inadequate glycaemic control using metformin alone were randomly allocated to fotagliptin or placebo at a 2:1 ratio for 24-week double-blind treatment period, followed by an open-label treatment with fotagliptin for all patients, making up a total of 52 weeks. All eligible patients were treated with a stable dose of metformin (≥1500 mg per day). The primary endpoint was the change in HbA1c level from baseline to week 24. Safety was ass

SUBMITTER: Yu N 

PROVIDER: S-EPMC12146461 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature