The study design and methods for the FPG GOAL study (ClinicalTrials.gov identifier NCT02545842) have been reported previously [23 (link), 24 (link)]. Briefly, FPG GOAL enrolled individuals with T2D and an HbA1c > 53 mmol/mol (> 7.0%) to ≤ 91 mmol/mol (≤ 10.5%) and FPG > 7 mmol/L despite receiving stable doses of 1–3 OADs for at least 3 months. Participants were randomly assigned (1:3:3) to one of three self-monitored FBG target groups: > 3.9 to ≤ 5.6 mmol/L, > 3.9 to ≤ 6.1 mmol/L, or > 3.9 to ≤ 7.0 mmol/L. Subcutaneous once-daily insulin glargine 100 U/mL (Lantus® SoloSTAR®, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany) was initiated at a dose of 0.2 U/kg and was titrated over the 24-week treatment period using a pre-defined titration algorithm.
The study was conducted in accordance with the principles stated in the Declaration of Helsinki and in line with the International Conference on Harmonization guidelines for good clinical practice. An institutional review board at each site approved the study, and all participants gave written informed consent.
The study was conducted in accordance with the principles stated in the Declaration of Helsinki and in line with the International Conference on Harmonization guidelines for good clinical practice. An institutional review board at each site approved the study, and all participants gave written informed consent.
