American Diabetes Association
DUAL.High.Supplem.05.18.2023.pdf (268.74 kB)

A Randomized Controlled Trial Comparing the Efficacy and Safety of IDegLira versus Basal-Bolus in Patients with Poorly Controlled Type 2 Diabetes and Very High HbA1c > 9-15%: DUAL HIGH trial

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posted on 2023-07-17, 19:56 authored by Rodolfo J. Galindo, Bobak Moazzami, Maria F. Scioscia, Cesar Zambrano, Bonnie S. Albury, Jarrod Saling, Priyathama Vellanki, Francisco J. Pasquel, Georgia M. Davis, Maya Fayfman, Limin Peng, Guillermo E Umpierrez

Introduction: In participants with type 2 diabetes (T2D) and HbA1c >9.0-10.0%, guidelines recommend treatment with basal-bolus insulin. 

Methods: Randomized trial comparing the efficacy and safety of IDegLira and basal-bolus among participants with high HbA1c >9.0-15.0%, previously treated with 2-3 oral agents and/or basal insulin, allocated (1:1) to basal-bolus (n=73) or IDegLira (n=72). Primary endpoint was non-inferiority (0.4%) in HbA1c reduction between groups. 

Results: Among 145 participants (HbA1c 10.8%±1.3), there was no statistically significant difference in HbA1c reduction (3.18%±2.29 vs. 3.00%±1.79, p=0.65, ETD 0.18%, 95%CI: -0.59, 0.94); between IDegLira and basal-bolus group. IDegLira resulted in significantly lower rates of hypoglycemia < 70 mg/dl (26% vs. 48%, p=0.008, ORs 0.39, 95% CI 0.19, 0.78), and less weight gain (1.24±8.33 vs. 5.84±6.18 kg, p=0.001, ETD -4.60, 95% CI -7.33, -1.87).  

Conclusions: In participants with T2D and HbA1c >9.0-15.0%, IDegLira resulted in similar HbA1c reduction, less hypoglycemia, less weight gain, compared to basal-bolus regimen. 


This study was an investigator-initiated clinical trial funded by a grant from Novo Nordisk. A contract was developed between Novo Nordisk and Emory University (PI: Rodolfo J. Galindo), which became the academic sponsor of the study. The funder of the study had no role in study design, data analysis, and interpretation, or writing of the report.


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