Efficacy and safety of Efsubaglutide Alfa in “overrun” patients in the SUPER2 trial: A post‐hoc analysis for comprehensive evaluation
Primary result · Change in HbA1cResult — go to the resultPlacebo-corrected difference −0.95 % 95% CI −1.25 to −0.65Authors' conclusion
Efsubaglutide Alfa 1 mg provided clinically meaningful glucose lowering with good tolerability but without significant weight loss. These results support a lower-dose strategy for elderly or frail patients, those with low BMI, or individuals sensitive to gastrointestinal effects, and as a possible lead-in step before escalation. Confirmatory trials are warranted to establish long-term outcomes.
Study context
- Population
- Patients with T2D inadequately controlled on metforminoverrun cohort
- Participants
- 155 patients
- Comparison
- Once-weekly Efsubaglutide Alfa 1 mg vs placebo, on metformin
- Primary endpoint
- Change in HbA1c
- Follow-up
- Week 24
Methodological detailsphase 2b/3, double-blind, placebo-controlled, overrun cohort, After 24 weeks of double-blind 1 mg, patients entered 28 weeks of open-label 3 mg and 4 weeks of follow-up
- Phase 2b/3
- Double-blind
- Placebo-controlled
- Overrun cohort
- After 24 weeks of double-blind 1 mg, patients entered 28 weeks of open-label 3 mg and 4 weeks of follow-up
Primary result
As reported in the abstract
Placebo-corrected difference
−0.95 %
95% CI −1.25 to −0.65
P < 0.0001
Change by group
Efsubaglutide Alfa 1 mg
−1.69
95% CI −1.91–-1.47 · %
Placebo
−0.74
CI −0.96–-0.52 · %
Secondary outcomes
HbA1c <7.0%
OR 8.3 · P < 0.0001
mmol/L
| Outcome | Efsubaglutide Alfa 1 mg | Placebo | Difference (mmol/L) | P value |
|---|---|---|---|---|
| Change in FPG · week 24 | −2.09 | −0.50 | - 1.59 | P < 0.001 |
Body weight
- Body weight reduction was modest and not significant
- P = 0.137
Safety
Adverse events
- Drug-related serious events
- 0
- GI AEs most common, generally mild and transient
Original publication
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