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Cost and tolerability matter too
Native GLP-1 has been infused by the subcutaneous route (4.8 pmol/kg/min) using a portable insulin pump in a non-randomized study of subjects with type 2 diabetes over the age of 40 (mean age 55) with mean initial HbA1c of about 9%, and mean fasting glucose ~14 mM
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There are steps worth taking before giving up on coverage entirely
FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data
In cardiovascular outcome trials (CVOTs) such as Empagliflozin Cardiovascular Outcome Event Trial in Type 2 diabetes Mellitus Patients (EMPA-REG OUTCOME), CANagliflozin cardioVascular Assessment Study (CANVAS) and The Dapagliflozin Effect on Cardiovascular EventsThrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58) [6], they reduced the onset and progression of DKD, which was confirmed in the dedicated kidney trial The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), which showed a canagliflozin-induced risk reduction for ESKD in people with DKD by 32% [7]
