Study design
hyperglycemia, diabetes
HYPERGLYCEMIA, RECRUITMENT, TYPE 2 DIABETES, DIABETES
The three-arm trial design of BEYOND has been described previously [BEYOND was a 6-month, randomized, pragmatic, parallel group, single-center trial that evaluated the efficacy and safety of either FRC or basal insulin plus SGLT-2i to replace a full basal-bolus insulin regimen in participants with type 2 diabetes experiencing inadequate glycemic control (HbA1c > 7.5% [58 mmol/mol]), with or without metformin. The active control group consisted of patients continuing the basal-bolus regimen with their usual diabetes care. Recruitment started in July 2019 and the first part of the trial was completed in 2020 after a follow-up of 6 months. The present report consists of the data obtained up to 30 November 2022, when the last patient competed 2 years after randomization.Originally, 101 participants were randomly assigned to intensification of basal-bolus regimen, 102 to the FRC group, and 102 to the gliflo-combo group. There were 12 dropouts in the FRC group, 9 in the gliflo-combo group, and none in the basal-bolus group. In the extension phase of the trial, the investigators may suspend the medication for safety reasons or for uncontrolled hyperglycemia (i.e., HbA1c higher than the baseline value in the first assessment). Participants in both the FRC and gliflo-combo groups who withdrew from the study due to lack of treatment efficacy returned to the basal-bolus therapy but were not included in the original basal-bolus group.