Incident and recurrent hypoglycaemia with linagliptin and glimepiride over a median of 6 years in the CAROLINA cardiovascular outcome trial
Authors' conclusion
Across the severity spectrum, linagliptin substantially reduced the hypoglycaemic burden versus glimepiride in patients with relatively early type 2 diabetes at increased cardiovascular risk.
Study context
- Population
- Patients with relatively early T2D at increased cardiovascular risk
- Participants
- 3,014 vs 3,000
- Comparison
- Linagliptin vs glimepiride, added to standard care
- Linagliptinn = 3,014
- Glimepiriden = 3,000reference
- Primary endpoint
- Total hypoglycaemic burden: first and total (first plus recurrent) investigator-reported hypoglycaemia events
- Follow-up
- 6.3 years median
Methodological detailspre-specified and post-hoc analyses
- Pre-specified and post-hoc analyses
Primary result
As reported in the abstract
Investigator-reported hypoglycaemia
Each group vs glimepirideEstimate (95% CI)
Linagliptin
rate ratio (first events) 0.21(0.19–0.24)
Linagliptin
rate ratio (total events) 0.12(0.10–0.14)
- Estimated first events prevented/100 patient-years with linagliptin vs glimepiride
- 8.7
- Estimated total events prevented/100 patient-years with linagliptin vs glimepiride
- 60.8
Further findings
| Outcome | Weighted mean difference (%) (95% CI) | |
|---|---|---|
| Average HbA1c over time | 0.00 (−0.05 to 0.05) | |
| −0.06−0.04−0.0200.020.040.06Difference, % (linear scale) |
Insulin initiation
| Outcome | Difference (kg) (CI) | |
|---|---|---|
| Body weight | −1.54 (−1.80 to −1.28) | |
| −2−101Difference, kg (linear scale) |
Insulin initiation
- Did not differ
Total hypoglycaemia events in subgroups
- Differences also occurred in subgroup analyses of total events
Original publication
Incident and recurrent hypoglycaemia with linagliptin and glimepiride over a median of 6 years in the CAROLINA cardiovascular outcome trial. Diabetes Obes Metab. Published 14 February 2023. doi:10.
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