Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial
Primary result · Change from baseline in HbA1cResult — go to the resultLS mean difference 0.05 % 95% CI −0.13 to 0.22Authors' conclusion
Alternating doses of SAR-Asp and NN-Asp compared with continuous use of NN-Asp showed similar safety, immunogenicity, and clinical efficacy in adults with T1D. This study supports interchangeability between SAR-Asp and NN-Asp in T1D management.
Study context
- Population
- Adults with T1D treated with MDI, using once-daily insulin glargine U100 as basal insulin200 (95.5%) completed
- Participants
- 210 adults
- Comparison
- Alternating SAR-Asp and NN-Asp vs continuous NN-Asp
- Switchingn = 104
- Nonswitchingn = 106reference
Methodological detailsopen-label, randomized (1:1), parallel-group, phase 3
- Open-label
- Randomized (1:1)
- Parallel-group
- Phase 3
Primary result
Change from baseline in HbA1c · week 16
LS mean difference
0.05 %
95% CI −0.13 to 0.22
Switchingvs Nonswitching
LS mean difference 0.05 % (95% CI −0.13 to 0.22)
As reported in the abstract
Further findings
| Outcome | LS mean difference (mmol/L) (95% CI) | |
|---|---|---|
| Change from baseline in FPG · week 164.12 mg/dL [−19.38, 27.62] | 0.23 (−1.08 to 1.53) | |
| −2−1012Difference, mmol/L (linear scale) |
Changes in insulin dosages · week 16
- No relevant difference between switching vs nonswitching
Safety
Safety and tolerability, incl. anti-insulin aspart antibody responses, adverse events and hypoglycemia
- Similar safety and tolerability in switching and nonswitching groups
Original publication
Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial. J Diabetes Sci Technol. Published 29 February 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →