Comparison of insulin degludec (IDeg)/insulin Aspart (IAsp) co‐formulation therapy twice‐daily with free combination of GLP‐1 receptor agonist liraglutide plus insulin degludec in Tochigi: IDEAL Trial. Issue 4 (9th November 2020)

• Record Type: Journal Article
• Authors: Aso, Yoshimasa; Takada, Yoshihisa; Tomotsune, Ken; Chiba, Yasuko; Matsumura, Mihoko; Jojima, Teruo; Sato, Minoru; Fujita, Nobuya; Kuroda, Hisamoto; Murano, Shunichi; Usui, Isao
• Is Part Of: International journal of clinical practice. Volume 75:Issue 4(2021)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-11-09
• Subjects: Clinical medicine -- Periodicals; Medicine -- Periodicals; 610.5
• DOI: 10.1111/ijcp.13734
• Languages: English
• ISSNs: 1368-5031

Abstract

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 as follows: 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 hypoglycaemia 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 with the twice‐daily single injection of IDegAsp showed no significant difference in glycaemic control but statistically superior weight loss.