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Randomized Controlled Trial
. 2023 Sep 1;46(9):1640-1645.
doi: 10.2337/dc22-2426.

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

Rodolfo J Galindo  1 , Bobak Moazzami  1 , Maria F Scioscia  1 , Cesar Zambrano  1 , Bonnie S Albury  1 , Jarrod Saling  1 , Priyathama Vellanki  1 , Francisco J Pasquel  1 , Georgia M Davis  1 , Maya Fayfman  1 , Limin Peng  2 , Guillermo E Umpierrez  1
Affiliations
Randomized Controlled Trial

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

Rodolfo J Galindo et al. Diabetes Care. .

Abstract

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

Research design and methods: This randomized trial compared the efficacy and safety of insulin degludec and liraglutide (IDegLira) and basal-bolus among participants with high HbA1c ≥9.0-15.0%, previously treated with 2 or 3 oral agents and/or basal insulin, allocated (1:1) to basal-bolus (n = 73) or IDegLira (n = 72). The primary end point was noninferiority (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; estimated treatment difference (ETD) 0.18%, 95% CI -0.59, 0.94) between the IDegLira and basal-bolus groups. IDegLira resulted in significantly lower rates of hypoglycemia <70 mg/dL (26% vs. 48%, P = 0.008; odds ratio 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, and less weight gain compared with the basal-bolus regimen.

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Conflict of interest statement

Duality of Interest. This study was an investigator-initiated clinical trial funded by a grant from Novo Nordisk (IIS to Emory University). A contract was developed between Novo Nordisk and Emory University (primary investigator: R.J.G.), which became the academic sponsor of the study. R.J.G. received unrestricted research support (to Emory University) from Novo Nordisk, Eli Lilly and Dexcom Inc., and consulting fees from Sanofi, Novo Nordisk, Eli Lilly, Pfizer, Boehringer, Bayer, and Weight Watchers. P.V. has received consulting fees from Merck and Boehringer-Ingelheim. F.J.P. has received consulting fees from Merck, Boehringer-Ingelheim, Eli Lilly, and Medscape, and research support from Merck, Ideal Medical Technologies, Insulet, and Dexcom Inc. G.M.D. and has received research support from Insulet and consulting fees from Medscape. M.F. receives research support from Dexcom Inc. G.E.U. has received research support (to Emory University) from Bayer, Abbott, and Dexcom.

Figures

None
Graphical abstract
Figure 1
Figure 1
Participant flow diagram.
Figure 2
Figure 2
Efficacy and composite outcomes. A: HbA1c change from baseline (week 12, and week 26). B: Change in body weight from baseline to week 26. C: Participants achieving composite outcomes: efficacy (HbA1c) targets and safety (hypoglycemia and/or weight) targets, from baseline to week 26. *P < 0.05. Data are presented as mean ± SD, except where otherwise noted.
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