751-P: Benefits of HR17031, a Fixed-Ratio Combination of INS068 and SHR20004, vs. Its Components Alone in Patients (pts) with Type 2 Diabetes (T2D) Uncontrolled on Oral Antidiabetic Drug(s) (OADs)

Introduction & Objective: HR17031 is a once-daily, novel combination of basal insulin analogue (INS068) and GLP-1 receptor agonist (SHR20004). This trial assessed efficacy and safety of HR17031 vs INS068 and SHR20004 in pts with T2D.

Methods: In this randomized phase 2 trial, 455 Chinese adults with T2D (HbA1c 7.5%-11.0%; previous metformin±another OAD) were randomized (2:2:1) to daily injections of HR17031 (n = 183), INS068 (n = 182) or SHR20004 (0.12 mg/d; n = 90). Primary outcome was HbA1c change at 26 weeks.

Results: After 26 weeks, greater reduction in HbA1c from baseline was achieved with HR17031 compared with INS068 and SHR20004 (-2.4% vs -1.5% and -1.7%; Fig 1), indicating superiority for HR17031 vs both INS068 (difference [D] = -0.9%) and SHR20004 (D = -0.7%). More pts reached HbA1c target <7% and <6.5% with HR17031 (<7%, 81.4%; <6.5%, 74.3%) than INS068 (47.8%; 26.4%) and SHR20004 (55.6%; 41.1%). HR17031 led to weight loss in contrast to INS068 (-0.1 vs 2.0 kg). Insulin dose of HR17031 was lower than INS068 (30.3 vs 38.1 U/d). All the above results were statistically significant (all P <0.001). Documented <3.0 mmol/L hypoglycemia was similar with HR17031 (5.5%) and INS068 (4.4%). No unexpected safety issues occurred.

Conclusion: HR17031 is effective and well-tolerated in pts with T2D uncontrolled on OAD(s).

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