QWINT-2
Trial question
Is insulin efsitora noninferior to insulin degludec in patients with T2DM without previous insulin treatment?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 928
928 patients (382 female, 546 male).
Inclusion criteria: adult patients with T2DM who had not previously received insulin.
Key exclusion criteria: T1DM, latent autoimmune diabetes, or specific type of diabetes other than T2DM; history of > 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization in the past 6 months; severe hypoglycemia episodes in the past 6 months; hemoglobin abnormalities.
Interventions
N=466 insulin efsitora (insulin efsitora alfa SC once weekly).
N=462 insulin degludec (insulin degludec SC once daily).
Primary outcome
Reduction in mean glycated hemoglobin level at week 52
1.26%
1.17%
1.3 %
0.9 %
0.6 %
0.3 %
0.0 %
Insulin
efsitora
Insulin
degludec
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in reduction in mean glycated hemoglobin level at week 52 (1.26% vs. 1.17%; MD 0.09, 95% CI -0.04 to 0.22).
Secondary outcomes
Significant increase in the rate of time the glucose level was within the target range in week 48 through 52 (64.3% vs. 61.2%; AD 3.1%, 95% CI 0.1 to 6.1).
No significant difference in reduction in mean glycated hemoglobin level at week 52 in patients using GLP-1 receptor agonists (1.26% vs. 1.19%; MD 0.06, 95% CI -0.13 to 0.26).
No significant difference in reduction in mean glycated hemoglobin level at week 52 in patients not using GLP-1 receptor agonists (1.26% vs. 1.15%; MD 0.11, 95% CI -0.07 to 0.28).
Safety outcomes
No significant differences in combined clinically significant or severe hypoglycemia, adverse events.
Conclusion
In adult patients with T2DM who had not previously received insulin, insulin efsitora was noninferior to insulin degludec with respect to reduction in mean glycated hemoglobin level at week 52.
Reference
Carol Wysham, Harpreet S Bajaj, Stefano Del Prato et al. Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. 2024 Dec 12;391(23):2201-2211.
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