Approaches To Therapy Escalation In T2D

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
This cluster‐based study will be conducted in a Primary Care clinical practice setting in Canada. A total of approximately 60 physician practices will be stratified into single (1 PCP) or group (>1 PCP) practices and randomized 1:1 into two arms each consisting of approximately 30 Primary Care practices forming the Interventional arm and the Control arm. The study population will include approximately 600 male and female adult participants living in Canada; who have been diagnosed with T2D; who are being treated for this condition by their PCP; who do not have clinical cardiovascular disease (CVD) and whose eGFR is ≥ 60ml/min; who are receiving metformin at a dose of ≥1500 mg/day as monotherapy for T2D; who are not at the target for glycemic control and whose most recent A1C level is between 7.1 % and 9.0 %. Participant enrollment may be adjusted to ensure balanced distribution of glycemic values at entry across this range between study arms. All physicians in both arms will receive training on the most current Diabetes Canada 2018 Guidelines for pharmacologic management of type 2 diabetes and the role of DPP‐4 inhibitors or SGLT2 inhibitors as add‐on therapy to metformin. Physicians in the Interventional arm will receive additional training on specific individualized management for adding DPP‐4 inhibitors or SGLT2 inhibitors to metformin. The nature of the additional training will be described separately in a physician training manual. To avoid contamination, only physicians who have been randomized to the Interventional arm will be given access to the physician training manual during the operation of the study, while those physicians randomized into the Control arm will continue to follow their routine clinical practice for utilizing DPP‐4 inhibitors or SGLT2 inhibitors as add‐on to metformin according to the current Diabetes Canada Practice Guidelines.
Epistemonikos ID: f9bde7f3968f87fa57c90384777888117300a5b2
First added on: May 21, 2024