IDegLira Improves Glycemic Control in Japanese Patients with Uncontrolled Type 2 Diabetes on Premixed Insulin Therapy

Hirotaka Watada; Bue F Ross Agner; Ankur Doshi; Lars Bardtrum; Mattis Flyvholm Ranthe; Liana K Billings

doi:10.1007/s13300-019-00730-y

IDegLira Improves Glycemic Control in Japanese Patients with Uncontrolled Type 2 Diabetes on Premixed Insulin Therapy

Diabetes Ther. 2020 Jan;11(1):331-339. doi: 10.1007/s13300-019-00730-y. Epub 2019 Nov 23.

Authors

Hirotaka Watada¹, Bue F Ross Agner², Ankur Doshi³, Lars Bardtrum², Mattis Flyvholm Ranthe², Liana K Billings^{4

5}

Affiliations

¹ Department of Metabolism and Endocrinology, Juntendo University, Tokyo, Japan. hwatada@juntendo.ac.jp.
² Novo Nordisk A/S, Søborg, Denmark.
³ PrimeCare Medical Group, Houston, TX, USA.
⁴ NorthShore University HealthSystem, Skokie, IL, USA.
⁵ University of Chicago Pritzker School of Medicine, Skokie, IL, USA.

Abstract

Introduction: DUAL II Japan (NCT02911948) was a 26-week, phase 3a randomized, treat-to-target trial which compared the efficacy and safety of IDegLira with degludec in 210 Japanese patients with type 2 diabetes (T2D) uncontrolled on premixed or basal insulin therapy. The DUAL II Japan trial presented the opportunity for a post hoc analysis to examine the safety and efficacy of switching patients from a premixed regimen (containing both basal and bolus insulin components) to IDegLira.

Methods: Patients from DUAL II Japan were stratified according to prior insulin regimen (premixed or basal insulin). The following endpoints were assessed in this post hoc analysis by pre-trial insulin regimen: change in HbA_1c, body weight, daily total insulin dose, nine-point self-measured blood glucose, and severe or blood glucose-confirmed hypoglycemia (defined as severe or plasma glucose less than 56 mg/dL).

Results: This post hoc analysis included 39 patients who switched from premixed insulin to IDegLira. The treatment effect in this population was independent of insulin type at baseline (premixed or basal; interaction test, P = 0.2535). In patients switching from premixed insulin to IDegLira, mean [standard deviation (SD)] HbA_1c was 8.26% (0.73) at baseline and 6.68% (0.93) at week 26. Mean (SD) body weight was reduced by 1.5 (2.9) kg. At week 26, daily insulin dose was 34.2 dose steps. After 26 weeks, the mean prandial increment was smaller at all meals with IDegLira irrespective of pre-trial insulin regimen. Rate of hypoglycemic events was 2.59 events/patient-year of exposure over the 26 weeks.

Conclusion: This post hoc study is the first to evaluate the switch from premixed insulin to IDegLira in patients with uncontrolled T2D. IDegLira initiation resulted in improved HbA_1c and weight loss. This study offers insight into the effectiveness and safety of switching patients from premixed insulin therapy to IDegLira, and provides support for further investigation.

Trial registration: NCT02911948.

Keywords: Basal insulin; Hypoglycemia; Liraglutide; Premixed insulin; Randomized trial; Type 2 diabetes.

Associated data

ClinicalTrials.gov/NCT02911948