Effect of ipragliflozin on carotid intima-media thickness in patients with type 2 diabetes: a multicenter, randomized, controlled trial
Primary result · Change in mean CCA-IMTResult — go to the resultEstimated group difference −0.0001 mm 95% CI −0.0191-0.0189Authors' conclusion
Twenty-four months of ipragliflozin treatment did not affect carotid IMT status in patients with type 2 diabetes recruited in the PROTECT study, relative to the non-SGLT2 inhibitor-use standard care for type 2 diabetes.
Study context
- Population
- Adults with T2DM and haemoglobin A1C (HbA1c) 6.0–10.0% (42–86 mmol/mol)464 analysed
- Participants
- 482 adults
- Comparison
- Ipragliflozin vs non-SGLT2 inhibitor standard care
- Ipragliflozinn = 241
- Controln = 241reference
- Primary endpoint
- Change in mean common carotid artery intima-media thickness (IMT) (common carotid artery IMT (CCA-IMT))
- Follow-up
- Baseline to 24 months
Methodological detailsmulticentre, prospective, open-label, blinded-endpoint, investigator-initiated
- Multicentre
- Prospective
- Open-label
- Blinded-endpoint
- Investigator-initiated
Primary result
Change in mean CCA-IMT · up to 24 months
Estimated group difference
−0.0001 mm
95% CI −0.0191-0.0189
P = 0.989
Change by group
Ipragliflozin
0.0013
change · 95% CI −0.0155–0.0182 · mm
Control
0.0015
change · 95% CI −0.0155–0.0184 · mm
Ipragliflozinvs Control
estimated group difference −0.0001 mm (95% CI −0.0191-0.0189); P = 0.989
As reported in the abstract
Further findings
HbA1c change · up to 24 months
- Non-significant group difference in HbA1c change between the treatment groups: −0.1% (95% CI, −0.2-0.1)
- P = 0.359
Original publication
Effect of ipragliflozin on carotid intima-media thickness in patients with type 2 diabetes: a multicenter, randomized, controlled trial. Eur Heart J Cardiovasc Pharmacother. Published 29 October 2022. doi:10.
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