Rationale and Design for the J-DISCOVER Study: DISCOVERing the Treatment Reality of Type 2 Diabetes in a Real-World Setting in Japan-A Protocol.

Introduction: It is estimated that 642 million adults worldwide will have diabetes by 2040, with 80-90% of these having type 2 diabetes mellitus (T2DM). While many new antidiabetic agents have been introduced in recent years, approximately 40% of T2DM patients still fail to achieve the recommended target HbA1c of < 7.0%.

Patterns of glycaemic control in patients with type 2 diabetes mellitus initiating second-line therapy after metformin monotherapy: Retrospective data for 10 256 individuals from the United Kingdom and Germany.

Aim: To investigate determinants of change in glycated haemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM) at 6 months after initiating uninterrupted second-line glucose-lowering therapies.

Materials And Methods: This cohort study utilized retrospective data from 10 256 patients with T2DM who initiated second-line glucose-lowering therapy (switch from or add-on to metformin) between 2011 and 2014 in Germany and the UK. Effects of pre-specified patient characteristics on 6-month HbA1c changes were assessed using analysis of covariance.

Towards an improved global understanding of treatment and outcomes in people with type 2 diabetes: Rationale and methods of the DISCOVER observational study program.

Aim: Contemporary global real-world data on the management of type 2 diabetes are scarce. The global DISCOVER study program aims to describe the disease management patterns and a broad range of associated outcomes in patients with type 2 diabetes initiating a second-line glucose-lowering therapy in routine clinical practice.

Methods: The DISCOVER program comprises two longitudinal observational studies involving more than 15,000 patients in 38 countries across six continents.

Safety, efficacy and pharmacokinetics of neratinib (HKI-272) in Japanese patients with advanced solid tumors: a Phase 1 dose-escalation study.

Objective: Neratinib (HKI-272), a potent, irreversible, small-molecule, orally administered, pan-ErbB inhibitor that blocks signal transduction via inhibition of three epidermal growth factor receptors [ErbB1, ErbB2 (Her2) and ErbB4], is being developed for the treatment of solid tumors, including breast cancer. This Phase 1 dose-escalation study assessed the safety, tolerability, maximum-tolerated dose, antitumor activity and pharmacokinetics of neratinib in Japanese patients with advanced solid tumors.

Methods: Patients received neratinib 80, 160, 240 or 320 mg orally; each patient enrolled in only one dose cohort.