Based on CONCLUDE,
which would you choose?28
Rate of hypoglycaemia
Rate ratio [95% CI]
Reduction in hypo
rates with TRESIBA®
vs glargine U300
The primary endpoint*
(superiority on rate of overall
symptomatic hypoglycaemia
in the maintenance period)
for Tresiba® vs glargine U300
was not met (not statistically
significant, although numerically
lower; rate ratio: 0.88; 95%
CI: 0.73 to 1.06).28
12%
37%
80%
23%
43%
62%
Maintenance
period
Overall*
Nocturnal
Severe
Total
treatment period
Overall
Nocturnal
Severe
0.88 [0.73–1.06]
0.63 [0.48–0.84]
0.20 [0.07–0.57]
0.77 [0.65–0.92]
0.57 [0.44–0.74]
0.38 [0.21–0.70]

- 0.0625
- 0.125
- 0.25
- 0.5
- 1
- 2

Favours Tresiba®
Favours glargine U300
Without compromising glycaemic control28†

i

- *Primary endpoint of the study was not met.28
- †Post hoc analysis that assessed change from baseline to end of treatment showed lower HbA1c in patients
  treated with Tresiba® vs glargine U300 (estimated treatment difference –0.10%; 95% CI: –0.18 to –0.02).28

The pre-specified confirmatory secondary hypoglycaemia endpoint, nocturnal symptomatic hypoglycaemia
during the maintenance period, is considered exploratory as it could not be controlled for the family-wise
type I error.28
Secondary endpoints should not be interpreted independently of the primary endpoint.28
Overall symptomatic hypoglycaemia was defined as severe or BG-confirmed.28
Nocturnal symptomatic hypoglycaemia was defined as severe or BG-confirmed, occurring between the times
of 00:01 and 05:59.28
Severe hypoglycaemia was defined as an event requiring third-party assistance as per the ADA definition.28,29
BG-confirmed events were defined as BG <3.1 mmol/L (<56 mg/dL), with symptoms.28
ADA (American Diabetes Association). BG (blood glucose). CI (confidence interval).