Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin
Primary result · Change in HbA1cResult — go to the resultEstimated between-group difference −0.19 percentage points 95% CI −0.36 to −0.03Authors' conclusion
Glycemic control was significantly better with once-weekly insulin icodec than with once-daily insulin glargine U100.
Study context
- Population
- Insulin-naive adults with T2D (HbA1c 7 to 11%)randomized 1:1
- Participants
- 492 vs 492
- Comparison
- Once-weekly insulin icodec vs once-daily insulin glargine U100
- Icodecn = 492
- Glargine U100n = 492reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 52
Methodological detailsopen-label, treat-to-target, phase 3a, 78-week (52-week main phase, 26-week extension, 5-week follow-up)
- Open-label
- Treat-to-target
- Phase 3a
- 78-week (52-week main phase, 26-week extension, 5-week follow-up)
Primary result
Change in HbA1c
Estimated between-group difference
−0.19 percentage points
95% CI −0.36 to −0.03
P < 0.001 for noninferiority; P = 0.02 for superiority
Change by group
Icodec
−1.55
mean · percentage points
Glargine U100
−1.35
mean · percentage points
Icodecvs Glargine U100
estimated between-group difference −0.19 percentage points (95% CI −0.36 to −0.03); P < 0.001 for noninferiority; P = 0.02 for superiority
As reported in the abstract
Secondary outcomes
| Outcome | Icodec | Glargine U100 | Estimated between-group difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Confirmatory secondary: % time in range 70 to 180 mg/dL (3.9 to 10.0 mmol/L) · weeks 48 to 52Superiority confirmed | 71.9% | 66.9% | 4.27 (1.92–6.62) | P < 0.001 | |
| −50510Difference, percentage points (linear scale) |
Safety
| Outcome | Icodec | Glargine U100 | Estimated rate ratio (95% CI) | |
|---|---|---|---|---|
| Combined clinically significant or severe hypoglycemia · week 52Events per person-year of exposure | 0.30 | 0.16 | 1.64 (0.98–2.75) | |
| Combined clinically significant or severe hypoglycemia · week 83Events per person-year of exposure | 0.30 | 0.16 | 1.63 (1.02–2.61) | |
| 0.20.5125Estimated rate ratio (log scale) |
Adverse events
- No new safety signals; incidences of adverse events similar in the two groups
Original publication
Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin. N Engl J Med. Published 24 June 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →