Assessment of three fasting plasma glucose targets for insulin glargine-based therapy in people with type 2 diabetes mellitus in China: study protocol for a randomized controlled trial

BACKGROUND: A large proportion of patients with T2DM in China do not meet accepted HbA1c targets despite the availability of guidelines that describe a treatment pathway for achieving glycemic control. The aim of this study is to identify the fasting plasma glucose (FPG) target that will provide the highest control rate of HbA1c <7 % in Chinese patients with T2DM treated with an insulin glargine-based regimen as an adjunct to an established OAD regimen. This information will support improvements in diabetes care management in China. METHODS: Approximately 934 men and women aged ≥18 to ≤65 years with poorly controlled T2DM will be enrolled and randomized to one of three FPG target groups; ≤5.6 mmol/L, ≤6.1 mmol/L, or ≤7.0 mmol/L. They will be initiated on daily insulin glargine (Lantus®) in addition to their usual OAD regimen for 24 weeks. Patients will self-monitor fasting blood glucose (SM-FBG), and the study physician will titrate the basal insulin dose according to the SM-FBG results. In addition, HbA1c and safety will be recorded. We plan to statistically derive the optimal FPG target for an HbA1c of <7 %. DISCUSSION: In China, treatment strategies that would achieve an optimum balance between glycemic control (as per HbA1c) and hypoglycemia are imperative to ensure improvements in the management of T2DM. Furthermore, elucidating the contribution of FPG to HbA1c in Chinese patients with T2DM and identifying a predictable relationship between FPG and HbA1c would be a valuable tool for patient self-management of diabetes. TRIAL REGISTRATION: NCT02545842. Registered on 8 September 2015.