Comparison of insulin degludec (IDeg)/insulin Aspart (IAsp)
co-formulation therapy twice-daily with free combination of GLP-1
receptor agonist liraglutide plus insulin deguldec in Tochigi: IDEAL
Trial
Abstract
Aim: We compared the efficacy and safety of insulin degludec/insulin
aspart co-formulation (IDegAsp) twice-daily to a free combination of
basal insulin degludec and GLP-1 receptor agonist liraglutide
(IDeg+Lira) once-daily for patients with inadequately controlled type 2
diabetes on insulin therapy and oral antidiabetic drugs. Subjects and
Methods: Eligible patients were randomly allocated at a 1:1 ratio to
receive either the once-daily dual-injection of IDeg+Lira (n=24) or
twice-daily single-injection of IDegAsp (n=28). The primary endpoints
were: HbA1c changes over 52 weeks of treatment and the percentage of
participants achieving HbA1c<7.0% at week 52. Results: After
52 weeks, HbA1c decreased by 0.3% in the IDegAsp group and by 0.7% in
the IDeg+Lira group. The HbA1c reduction was greater in the IDeg+Lira
group than in the IDegAsp group. 19% of patients on IDegAsp versus 40%
on IDeg+Lira achieved HbA1c<7.0%. Pre-breakfast and
pre-dinner blood glucose at 52 weeks were significantly lower in the
IDeg+Lira group than in the IDegAsp group. The reduction in body mass
index (BMI) was greater in the IDeg+Lira group than in the IDegAsp group
throughout the study period. The confirmed hypoglycemia rates were 1.32
and 0.69 per patient/year of exposure to IDegAsp and IDeg+Lira,
respectively. Conclusions: In patients with inadequately controlled type
2 diabetes on insulin therapy and oral antidiabetic drugs, treatment
with the once-daily dual-injection of IDeg+Lira compared to the
twice-daily single-injection of IDegAsp showed no significant difference
in glycemic control, but with a slightly larger reduction in HbA1c at 52
weeks, and statistically superior weight loss.