Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment
Primary result · Change in HbA1cResult — go to the resultEstimated treatment difference −0.09 percentage points 95% CI −0.22 to 0.04Authors' conclusion
In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora was noninferior to once-daily degludec in reducing glycated hemoglobin levels.
Study context
- Population
- Adults with T2D who had not previously received insulinrandomized 1:1
- Participants
- 928 adults
- Comparison
- Once-weekly efsitora vs once-daily degludec
- Efsitoran = 466
- Degludecn = 462reference
- Primary endpoint
- Change in HbA1c from baseline to week 52 (noninferiority margin 0.4 percentage points)
- Follow-up
- Week 52
Methodological details52-week, phase 3, parallel-design, open-label, treat-to-target, noninferiority
- 52-week
- Phase 3
- Parallel-design
- Open-label
- Treat-to-target
- Noninferiority
Primary result
Change in HbA1c · baseline to week 52
Estimated treatment difference
−0.09 percentage points
95% CI −0.22 to 0.04
Change by group
Efsitora
−1.26
least-squares mean change · percentage points
Degludec
−1.17
least-squares mean change · percentage points
Efsitoravs Degludec
estimated treatment difference −0.09 percentage points (95% CI −0.22 to 0.04)
As reported in the abstract
Further findings
| Outcome | Efsitora | Degludec | Estimated treatment difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| TIR 70 to 180 mg/dL · weeks 48 through 52 | 64.3% | 61.2% | 3.1 (0.1–6.1) | |
| −50510Difference, percentage points (linear scale) |
Change in HbA1c in subgroups using and not using GLP-1 RA
- Efsitora noninferior to degludec for HbA1c change in participants using and not using GLP-1 RA
Safety
| Outcome | Efsitora | Degludec | Estimated rate ratio (95% CI) | |
|---|---|---|---|---|
| Combined clinically significant or severe hypoglycemiaEvents per participant-year of exposure | 0.58 | 0.45 | 1.30 (0.94–1.78) | |
| 0.512Estimated rate ratio (log scale) |
Severe hypoglycemia
- Severe hypoglycemia episodes with degludec
- six episodes
- No severe hypoglycemia reported with efsitora
Adverse events
- The incidence of adverse events was similar in the two groups
Original publication
Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. Published 10 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →