Efficacy and safety of a fixed‐dose combination of dapagliflozin and linagliptin ( AJU ‐ A51 ) in patients with type 2 diabetes mellitus: A multicentre, randomized, double‐blind, parallel‐group, placebo‐controlled phase III study
Primary result · HbA1c (baseline to week 24)Result — go to the resultLeast squares mean difference −0.88 % 95% CI −1.07 to −0.68Authors' conclusion
Dapagliflozin and linagliptin FDC (AJU-A51) showed potent glucose-lowering effects, with good tolerability, in patients with T2D who had poor glycaemic control on metformin and linagliptin
Study context
- Population
- Patients with T2D with inadequate response to metformin (≥1000 mg/day) plus linagliptin (5 mg/day)
- Participants
- 235 patients
- Comparison
- Dapagliflozin/linagliptin FDC vs linagliptin plus placebo
- AJU-A51n = 117
- Linagliptin plus placebon = 118reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsmulticentre, double-blind, parallel-group, placebo-controlled, phase III, After 24 weeks, linagliptin plus placebo patients received AJU-A51 for an additional 28 weeks
- Multicentre
- Double-blind
- Parallel-group
- Placebo-controlled
- Phase III
- After 24 weeks, linagliptin plus placebo patients received AJU-A51 for an additional 28 weeks
Primary result
HbA1c (baseline to week 24) · 24 weeks
Least squares mean difference
−0.88 %
95% CI −1.07 to −0.68
P < 0.0001
By group
AJU-A51vs Linagliptin plus placebo
least squares mean difference −0.88 % (95% CI −1.07 to −0.68); P < 0.0001
As reported in the abstract
Further findings
HbA1c <7.0% · Week 24
P < 0.001
Glycaemic efficacy in extension period · up to 52 weeks
- AJU-A51 maintained glycaemic efficacy up to 52 weeks; control showed substantial HbA1c reduction after switching to AJU-A51
Safety
- Symptomatic hypoglycaemia
- 0 cases
- Similar incidence of treatment-emergent and serious adverse events in both groups
Original publication
Efficacy and safety of a fixed‐dose combination of dapagliflozin and linagliptin ( AJU ‐ A51 ) in patients with type 2 diabetes mellitus: A multicentre, randomized, double‐blind, parallel‐group, placebo‐controlled phase III study. Diabetes Obes Metab. Published 7 October 2024. doi:10.
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