1681-P: Benefits of HR17031 vs. Insulin Glargine (iGlar) in Patients (pts) with Type 2 Diabetes (T2D) Uncontrolled on Metformin (Met) with/without One Other Oral Antidiabetic Drug (OAD)

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Introduction and Objective: HR17031 is a once-daily, novel combination of basal insulin analogue (insulin sudelidec) and GLP-1 receptor agonist (noiiglutide). This randomized, treat to target Phase 3 trial evaluated the efficacy and safety of HR17031 vs iGlar in pts with T2D uncontrolled on Met with/without one other OAD. Methods: 401 Pts with T2D (HbA1c 7.5%-11.0%; previous Met ± another OAD) were randomized (1:1) to open-label once-daily HR17031 or iGlar for 26-week (wk) treatment. Then all pts entered 26-wk extension treatment with the iGlar group switching to HR17031. Primary outcome was change in HbA1c after 26 wks. Results: At 26 wks, HR17031 was superior to iGlar in HbA1c reductions from baseline (LSM: −1.85% vs −1.06%). More pts achieved HbA1c target <7%, <6.5% and <7.0% without weight gain in HR17031(66.8%, 50.5% and 20.3%) than iGlar (38.7%, 17.6% and 9.0%). HR17031 treatment was associated with less weight gain (LSM: 1.50 vs 2.79kg) and more FPG reduction than iGlar (LSM: -3.34 vs -2.83 mmol/L). The insulin dose of HR17031 was lower than iGlar (LSM: 23.0 vs 30.4 U/d). The incidence of Grade 2/3 hypoglycemic events was similar (2.0% vs 4.0%). Common HR17031-induced gastrointestinal adverse events were diarrhea (8.0%), abdominal distension (7.0%) and nausea (6.0%). Conclusion: HR17031 demonstrated superior efficacy in pts with T2D uncontrolled on OADs than iGlar with favorable safety profile. Disclosure L. Ji: None. L. Zhang: None. D. Liu: None. J. Liu: None. L. Li: None. Z. Zeng: None. X. Dong: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd. R. Li: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd. X. Wu: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Z. Ye: Employee; Current; Jiangsu Hengrui Pharmaceuticals Co., Ltd. Funding Jiangsu Hengrui Pharmaceuticals Co., Ltd.

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