Ultra‐rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double‐blind phase 3 study
Primary result · HbA1c change from baselineResult — go to the resultLeast squares mean treatment difference 0.07 % 95% CI −0.11 to 0.24Authors' conclusion
In this study, URLi administered in a basal-bolus regimen demonstrated superiority to insulin lispro in controlling PPG excursions, with noninferiority of HbA1c control in predominantly Chinese patients with T1D.
Study context
- Population
- Predominantly Chinese patients with T1D, after a lead-in optimising insulin glargine U-100 or insulin degludec U-100randomised 1:1
- Participants
- 176 vs 178
- Comparison
- Ultra-rapid lispro vs insulin lispro
- Ultra-rapid lispro (URLi)n = 176
- Insulin lispron = 178reference
- Primary endpoint
- Noninferiority of URLi to insulin lispro in HbA1c change from baseline (noninferiority margin 0.4%)
- Follow-up
- Week 26
Methodological detailsprospective, double-blind, treat-to-target, phase 3, noninferiority
- Prospective
- Double-blind
- Treat-to-target
- Phase 3
- Noninferiority
Primary result
HbA1c change from baseline
Least squares mean treatment difference
0.07 %
95% CI −0.11 to 0.24
P = 0.467
Change by group
URLi
0.21
%
Insulin lispro
0.28
%
URLivs Insulin lispro
least squares mean treatment difference 0.07 % (95% CI −0.11 to 0.24); P = 0.467
Non-inferiority margin 0.4 as printed, not drawn
As reported in the abstract
Further findings
| Outcome | Least squares mean treatment difference (mmol/L) | P value |
|---|---|---|
| 1-hour PPG excursion during mixed-meal tolerance test · week 26−17.8 mg/dL; smaller with URLi · multiplicity-adjusted superiority objective | −1.0 | P < 0.005 |
| 2-hour PPG excursion during mixed-meal tolerance test · week 26−25.5 mg/dL; smaller with URLi · multiplicity-adjusted superiority objective | −1.4 | P < 0.005 |
Safety
- Safety profiles of URLi and insulin lispro were similar
Original publication
Ultra‐rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double‐blind phase 3 study. Diabetes Obes Metab. Published 23 October 2023. doi:10.
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