Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial
Authors' conclusion
Once-weekly ecnoglutide 0.6 mg and 1.2 mg were non-inferior to dulaglutide 1.5 mg in reducing HbA1c in adults with type 2 diabetes and elevated glucose concentrations on metformin monotherapy. Although the 1.2 mg dose showed statistically significantly greater reductions in HbA1c from baseline to week 32 than dulaglutide 1.5 mg, the difference was not considered clinically relevant. Both doses of ecnoglutide were well tolerated. These results suggest that ecnoglutide might offer a new treatment option for type 2 diabetes.
Study context
- Population
- Adults aged 18–75 years, BMI 20–35 kg/m², T2D with elevated glucose on metformin monotherapy, 52 hospitals in China; mean age 53.9 years, mean HbA1c 8.40%621 in full analysis set
- Participants
- 623 adults
- Comparison
- Once-weekly ecnoglutide 0.6 mg or 1.2 mg vs dulaglutide 1.5 mg
- Ecnoglutide 0.6 mgn = 206
- Ecnoglutide 1.2 mgn = 208
- Dulaglutide 1.5 mgn = 207reference
- Primary endpoint
- Mean change from baseline in HbA1c (non-inferiority for both ecnoglutide doses, 0.4% margin; superiority for ecnoglutide 1.2 mg)
- Follow-up
- Week 32
Methodological detailsopen-label, active-controlled, non-inferiority, multicentre, phase 3, 52-week
- Open-label
- Active-controlled
- Non-inferiority
- Multicentre
- Phase 3
- 52-week
Primary result
As reported in the abstract
Ecnoglutide 0.6 mg
1.91
mean · SE 0.05 · %
Ecnoglutide 1.2 mg
1.89
mean · SE 0.05 · %
Dulaglutide 1.5 mg
1.65
mean · SE 0.05 · %
Further findings
- HbA1c reductions were sustained to week 52
Safety
Treatment discontinuation due to adverse events · 52 weeks
Original publication
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