Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy
Primary result · Change in HbA1cResult — go to the resultEstimated between-group difference −0.03 percentage points 95% CI −0.18 to 0.12Authors' conclusion
In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora, administered in a fixed-dose regimen, was noninferior to once-daily glargine in reducing glycated hemoglobin levels.
Study context
- Population
- Adults with T2D without previous insulin therapy; FPG target 80 to 130 mg per deciliterrandomized 1:1
- Participants
- 795 adults
- Comparison
- Once-weekly fixed-dose efsitora vs once-daily insulin glargine U100
- Primary endpoint
- Change from baseline in HbA1c, tested for noninferiority (margin 0.4 percentage points)
- Follow-up
- 52 weeks
Methodological detailsphase 3, open-label, treat-to-target, noninferiority, 52-week
- Phase 3
- Open-label
- Treat-to-target
- Noninferiority
- 52-week
Primary result
Change in HbA1c · week 52
Estimated between-group difference
−0.03 percentage points
95% CI −0.18 to 0.12
Change by group
Efsitora
−1.19
least-squares mean change · percentage points
Glargine
−1.16
least-squares mean change · percentage points
Efsitoravs Glargine
estimated between-group difference −0.03 percentage points (95% CI −0.18 to 0.12)
As reported in the abstract
Further findings
Mean, U per week
| Outcome | Efsitora | Glargine | Estimated between-group difference (U per week) (95% CI) | |
|---|---|---|---|---|
| Mean total weekly insulin dose · week 52 | 289.1 | 332.8 | −43.7 (−62.4 to −25.0) | |
| −100−50050Difference, U per week (linear scale) |
Median
| Outcome | Efsitora | Glargine |
|---|---|---|
| Number of dose adjustments | 2 | 8 |
Mean HbA1c, baseline to week 52
- Efsitora: 8.20% at baseline to 7.05% at week 52
- Glargine: 8.28% to 7.08%
Safety
| Outcome | Efsitora | Glargine | Estimated rate ratio (95% CI) | |
|---|---|---|---|---|
| Combined clinically significant (glucose <54 mg per deciliter) or severe (level 3) hypoglycemiaEvents per participant-year of exposure | 0.50 | 0.88 | 0.57 (0.39–0.84) | |
| 0.20.5125Estimated rate ratio (log scale) |
Original publication
Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. N Engl J Med. Published 22 June 2025. doi:10.
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