Efficacy and safety benefits of HR17031 , a fixed‐ratio combination of INS068 and noiiglutide, versus its components alone in Chinese patients with type 2 diabetes uncontrolled on oral antidiabetic drug(s): A phase 2, multicentre, open‐label, randomised, parallel three‐arm, treat‐to‐target trial
Authors' conclusion
HR17031 is effective and well-tolerated in patients with type 2 diabetes uncontrolled on metformin with or without a second oral antidiabetic drug.
Study context
- Population
- Chinese patients with T2D uncontrolled on metformin ± another oral antidiabetic drug (HbA1c 7.5%-11.0% [58.0–97.0 mmol/mol])randomised 2:2:1
- Participants
- 455 patients
- Comparison
- HR17031 vs INS068 vs noiiglutide
- HR17031n = 183
- INS068n = 182reference
- Noiiglutiden = 90reference
- Primary endpoint
- HbA1c change from baseline
- Follow-up
- Week 26
Methodological detailsphase 2, multicentre, open-label, parallel three-arm, treat-to-target
- Phase 2
- Multicentre
- Open-label
- Parallel three-arm
- Treat-to-target
Primary result
As reported in the abstract
Least-squares mean difference
−0.9 %
P < 0.0001
HR17031 vs INS068
Least-squares mean difference
−0.7 %
P < 0.0001
HR17031 vs noiiglutide
HR17031
−2.4
%
INS068
−1.5
%
Noiiglutide
−1.7
%
Further findings
HbA1c <7.0% (53 mmol/mol)
HbA1c ≤6.5% (48 mmol/mol)
kg
| Outcome | HR17031 | INS068 | Noiiglutide | P value |
|---|---|---|---|---|
| Body weight changeHR17031 vs INS068 | −0.1 | 2.0 | — not stated in the abstract | P < 0.0001 |
— not stated in the abstract
Safety
Level 2/3 hypoglycaemia
| Outcome | HR17031 | INS068 | Noiiglutide |
|---|---|---|---|
| Gastrointestinal AEs (nausea, diarrhoea, vomiting) | |||
| Nausea | 7.2% | — not stated in the abstract | 15.6% |
| Diarrhoea | 7.2% | — not stated in the abstract | 21.1% |
| Vomiting | 2.8% | — not stated in the abstract | 20.0% |
— not stated in the abstract
Level 2/3 hypoglycaemia
- Similar with HR17031 and INS068, lower with noiiglutide
Original publication
Efficacy and safety benefits of HR17031 , a fixed‐ratio combination of INS068 and noiiglutide, versus its components alone in Chinese patients with type 2 diabetes uncontrolled on oral antidiabetic drug(s): A phase 2, multicentre, open‐label, randomised, parallel three‐arm, treat‐to‐target trial. Diabetes Obes Metab. Published 27 August 2025. doi:10. 1111/ dom. 70036
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