Objective: To compare the efficacy and safety of insulin degludec/insulin aspart co-formulation (IDegAsp) twice daily with free combination of basal insulin degludec and GLP-1 receptor agonist liraglutide once daily in type 2 diabetic patients inadequately controlled on insulin therapy with oral antidiabetic drugs.
Subjects and Methods: Eligible patients were randomly allocated at a 1:1 ratio to receive once-daily IDeg plus liraglutide given separately (n=24) or twice daily IDegAsp (n=28). IDeg+Lira were separately administered before breakfast. The primary endpoints were the change in HbA1c from baseline to 52 weeks of treatment, as well as the percentage of participants achieving HbA1c less than 7.0% at 52 weeks.
Results: After 52 weeks, HbA1c was decreased by 0.3% in the IDegAsp group and by 0.7% in the IDeg+Lira group. Reduction in HbA1c tended to be greater in the IDeg+Lira group than in the IDegAsp group (P=0.070). Nineteen percent of patients on IDegAsp versus 40% on IDeg+Lira achieved HbA1c<7.0%. Pre-breakfast and -dinner FBP at 52 weeks were significantly lower in the IDeg+Lira group than in the IDegAsp group. A reduction in body mass index (BMI) was greater in the IDeg+Lira group than in the IDegAsp group throughout the study period. In the IDeg+Lira group, mean insulin degludec and liraglutide at 52 weeks were 15.1 U and 0.84 mg, respectively.
Conclusions: In patients with inadequately controlled type 2 diabetes on insulin and oral antidiabetic drugs, treatment with insulin degludec and liraglutide separately injections compared with IDegAsp co-formation twice daily showed no significant difference in glycemic control, but with somewhat greater reduction in HbA1c at 52 weeks, and a statistically superior weight loss.
Y. Aso: None. T. Jojima: None. S. Sakurai: None. T. Iijima: None. T. Tomaru: Research Support; Self; Merck & Co., Inc., Teijin Pharma Limited. I. Usui: None.