The efficacy and safety of iGlarLixi versus IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli‐D randomized controlled trial
Primary result · HbA1c change from baselineResult — go to the resultLS mean difference −0.20 95% CI −0.33 to −0.07Authors' conclusion
In Chinese people with T2D suboptimally controlled with OADs, once-daily iGlarLixi provided better glycaemic control with BW benefit and lower hypoglycaemia event rates versus IDegAsp.
Study context
- Population
- Insulin-naïve Chinese adults with T2D suboptimally controlled with OADs, continuing metformin ± SGLT2irandomized 1:1
- Participants
- 291 vs 291
- Comparison
- iGlarLixi vs IDegAsp
- iGlarLixin = 291
- IDegAspn = 291reference
- Primary endpoint
- Non-inferiority in HbA1c change from baseline
- Follow-up
- Week 24
Methodological detailsmulticentre, open-label, non-inferiority
- Multicentre
- Open-label
- Non-inferiority
Primary result
HbA1c change from baseline
LS mean difference
−0.20
95% CI −0.33 to −0.07
P < 0.001 for non-inferiority
iGlarLixivs IDegAsp
LS mean difference −0.20 (95% CI −0.33 to −0.07); P < 0.001 for non-inferiority
As reported in the abstract
Secondary outcomes
| Outcome | LS mean difference (97.5% CI) | P value | |
|---|---|---|---|
| Superiority in HbA1c change (key secondary) · week 24 | −0.20 (−0.35 to −0.05) | P = 0.003 for superiority | |
| −0.4−0.200.2Difference (linear scale) |
| Outcome | LS mean difference (kg) (97.5% CI) | P value | |
|---|---|---|---|
| Body weight change (key secondary) · baseline to week 24In favour of iGlarLixi | −1.49 (−2.32 to −0.66) | P < 0.001 | |
| −3−2−101Difference, kg (linear scale) |
Body weight change (key secondary) · baseline to week 24
- iGlarLixi decreased body weight (BW) and IDegAsp increased BW from baseline
Safety
Per person-year
| Outcome | iGlarLixi | IDegAsp | Relative risk (95% CI) | |
|---|---|---|---|---|
| ADA Level 1, 2 or 3 hypoglycaemia event rate (per person-year) | 1.90 | 2.72 | 0.71 (0.52–0.98) | |
| 0.512Relative risk (log scale) |
American Diabetes Association (ADA) Level 3 hypoglycaemia and unexpected safety findings
- No ADA Level 3 hypoglycaemia or unexpected safety findings reported
Original publication
The efficacy and safety of iGlarLixi versus IDegAsp in Chinese people with type 2 diabetes suboptimally controlled with oral antidiabetic drugs: The Soli‐D randomized controlled trial. Diabetes Obes Metab. Published 22 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →