Insulin therapy DE ‐ intensificAtion with iGlarLixi : A phase 4, open‐label, parallel‐group randomised controlled trial
Primary result · Change in HbA1cResult — go to the resultMean difference −0.12 % 95% CI −0.48 to 0.23Authors' conclusion
Insulin therapy simplification from MDI regimen to once-daily iGlarLixi is an efficient and safe treatment option for PwT2D.
Study context
- Population
- Adults with T2D on MDI (age 18–80 years, HbA1c ≤9% [75 mmol/mol], total daily insulin ≤0.8 IU/kg, fasting C-peptide above lower limit of normal); mean age 66.2 years, HbA1c 7.9%, body mass index (BMI) 33.6 kg/m²randomised 1:1
- Participants
- 90 adults
- Comparison
- Switch from MDI to once-daily iGlarLixi vs continued MDI
- iGlarLixin = 45
- MDIn = 45reference
- Primary endpoint
- Mean change in HbA1c from baseline between groups
- Follow-up
- 24 weeks
Methodological detailsfive-centre, open-label, parallel-group, active comparator, phase IV
- Five-centre
- Open-label
- Parallel-group
- Active comparator
- Phase IV
Primary result
Change in HbA1c
Mean difference
−0.12 %
95% CI −0.48 to 0.23
iGlarLixivs MDI
mean difference −0.12 % (95% CI −0.48 to 0.23)
As reported in the abstract
Further findings
| Outcome | Difference (kg) (CI) | |
|---|---|---|
| Body weight | −4.19 (−5.95 to −2.43) | |
| −10−505Difference, kg (linear scale) |
| Outcome | Difference (kg/m²) (CI) | |
|---|---|---|
| BMI | −1.49 (−2.11 to −0.86) | |
| −3−2−101Difference, kg/m² (linear scale) |
| Outcome | Difference (IU) (CI) | |
|---|---|---|
| Total daily insulin dose | −28.57 (−34.89 to −22.24) | |
| −40−20020Difference, IU (linear scale) |
| Outcome | Difference (%) (CI) | |
|---|---|---|
| Time in level 2 hyperglycaemia | −4.9 (−9.4 to −0.34) | |
| −10−505Difference, % (linear scale) |
| Outcome | Difference (CI) | |
|---|---|---|
| Glycaemia risk index | −13.6 (−25.1 to −2.1) | |
| −40−20020Difference (linear scale) |
Original publication
Insulin therapy DE ‐ intensificAtion with iGlarLixi : A phase 4, open‐label, parallel‐group randomised controlled trial. Diabetes Obes Metab. Published 15 December 2025. doi:10. 1111/ dom. 70362
Composed by AI from the published abstract and checked against it. How Briefs are made →