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
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.