Getting to goal
in the real world3
In the CONFIRM study, patients
with type 2 diabetes treated
with Tresiba® achieved:
.27%
Significantly greater reduction
in HbA1c vs glargine U3003*
27%
Reduced likelihood of treatment
discontinuation vs glargine U3003†

CONFIRM

i

- *Estimated treatment difference in HbA1c –0.27%; (p=0.03).3
- †Treatment with Tresiba® was 27% less likely to result in treatment discontinuation
  than treatment with glargine U300 (HR 0.73; p<0.001).3

CONFIRM was a retrospective, real-world study in insulin-naïve patients.3
HR (hazard ratio).
CONFIRM real-world study design3
4,056
insulin-naïve patients
with type 2 diabetes
RETROSPECTIVE DATA EXTRACTION
Insulin-naïve
(minimum 12 months)
Tresiba®
(minimum 3 months)
Insulin-naïve
(minimum 12 months)
Glargine U300
(minimum 3 months)
6 months
pre-initiation
3 months
Initiation of
basal insulin
3 months
6 months
post-initiation
Primary endpoint
Change in mean HbA1c
from initiation to 6 months
of follow-up
Secondary endpoints*
Change in rates of hypoglycaemic
episodes from initiation to
6 months of follow-up
Change in proportion of
patients with ≥1 episode of
hypoglycaemia from initiation
to 6 months of follow-up
As with all real-world studies, CONFIRM was not randomised. Therefore, this study carries the limitations of real-world evidence.3
POTENTIAL STUDY LIMITATIONS:3

- Potential under-reporting of hypoglycaemia (however, this is the case in both CONFIRM treatment arms, meaning the rate ratio and the odds ratio
  are expected to be preserved)
- Short follow-up period of 3–6 months (however, this corresponds to the time in which the largest changes in HbA1c tend to occur and is commonly
  used in many clinical trials)
- The study only provides evidence of prescribed basal insulin, not actual use (whether or not the medication was picked up at the pharmacy)

In the CONFIRM study, HbA1c values were estimated using repeated-measure analysis of covariance, treatment as factor and subject as random effect.3
Reduction in mean HbA1c was also significant (p=0.03; baseline HbA1c values – Tresiba®: 9.6 ± 2.2; glargine U300: 9.5 ± 2.1).3
Hypoglycaemia was recorded by the treating clinician and defined according to International Classification of Diseases codes 9 and 10.3†
Rate of hypoglycaemic episodes and proportion of patients with hypoglycaemia were estimated over a period of 180 days (pre- or post-initiation of basal insulin)
using negative binomial and logistic regression, respectively and a generalised estimating equation approach.3
† This definition differs from key Novo Nordisk RCTs with Tresiba® e.g., SWITCH 2 and DEVOTE.
Cl (confidence interval). RCT (randomised controlled trial).