Fixed-dose combinations of oral GLP-1 RAs with other glucose-lowering agents in development are still a rarity, and this is the first GLP-1 plus SGLT2 in one tablet.
HDM1010 tablets are a fixed-dose combination of an SGLT2 inhibitor and HDM1002, a potent, highly selective, orally active small-molecule GLP-1 receptor agonist — essentially an SGLT2/GLP-1 combo!
https://lnkd.in/eHKg-crF
In June 2025 Huadong Medicine received approval from the US Food and Drug Administration (FDA) for the clinical trial application of HDM1010 tablets, allowing Phase I clinical trials in the US for the treatment of type 2 diabetes.
HDM1010 may have unprecedented Combination Efficacy. In the publication authors speculate that HDM1010’s SGLT2-GLP-1 combo may outperform Zepbound’s dual GIP/GLP-1 mechanism in weight loss and glycemic control. But I am much more interested in “composite” efficacy for CVOT and renal outcomes.
In this population based cohort study with > 15000 patients https://www.bmj.com/content/385/bmj-2023-078242 the SGLT-2 inhibitor-GLP-1 receptor agonist combination was associated with a 30% lower risk of major adverse cardiovascular events (7.0 v 10.3 events per 1000 person years; hazard ratio 0.70, 95% confidence interval 0.49 to 0.99) and a 57% lower risk of serious renal events (2.0 v 4.6 events per 1000 person years; hazard ratio 0.43, 0.23 to 0.80), compared with GLP-1 receptor agonists alone.
However, in the updated in 2024 systematic review and meta-analysis of efficacy and safety of the combination or monotherapy with GLP-1 receptor agonists and SGLT-2 inhibitors in Type 2 diabetes mellitus authors concluded that:
The combination treatment of SGLT-2 inhibitors and GLP-1 receptor agonists effectively reduces HbA1c, FPG, and SBP without elevating the risk of hypoglycemia when compared to monotherapy with SGLT-2 inhibitors. However, these beneficial effects were not observed when the combination therapy was compared with GLP-1 receptor agonist treatment alone.
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