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

Galindo, RJ; Moazzami, B; Scioscia, MF; Zambrano, C; Albury, BS; Saling, J; Vellanki, P; Pasquel, FJ; Davis, GM; Fayfman, M; Peng, L; Umpierrez, GE

doi:10.2337/dc22-2426

Type 2 & other diabetes

A Randomized Controlled Trial Comparing the Efficacy and Safety of Insulin Degludec and Liraglutide (IDegLira) Versus Basal-Bolus in Patients With Poorly Controlled Type 2 Diabetes and Very High HbA1c ≥9–15%: DUAL HIGH Trial

Diabetes CarePublished 17 Jul 2023Randomised controlled trial

Primary result · HbA1c reductionResultEstimated treatment difference 0.18 % 95% CI −0.59 to 0.94

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Authors' conclusion

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.

Study context

Population: Participants with T2D and HbA1c ≥9.0–15.0%, previously treated with 2 or 3 oral agents and/or basal insulin; baseline HbA1c 10.8% ± 1.3allocated 1:1
Participants: 145 participants

Comparison: IDegLira vs basal-bolus insulin
IDegLiran = 72
Basal-bolusn = 73reference
Primary endpoint: Noninferiority (0.4%) in HbA1c reduction between groups

Methodological detailsnoninferiority

Noninferiority

Primary result

HbA1c reduction

Estimated treatment difference

0.18 %

95% CI −0.59 to 0.94

P = 0.65

By group

IDegLira3.18± 2.29 · %

Basal-bolus3.00± 1.79 · %

IDegLiravs Basal-bolus

estimated treatment difference 0.18 % (95% CI −0.59 to 0.94); P = 0.65

Non-inferiority margin 0.4 as printed, not drawn

As reported in the abstract

Further findings

Outcome	IDegLira	Basal-bolus	← Lower with IDegLira ←→ Higher with IDegLira →	Estimated treatment difference (95% CI)	P value
Weight gainLess weight gain with IDegLira	1.24 ± 8.33 kg	5.84 ± 6.18 kg	−10−505	−4.60 (−7.33 to −1.87)	P = 0.001
			−10−505Difference (linear scale)

Safety

Outcome	IDegLira	Basal-bolus	← Lower odds with IDegLira ←→ Higher odds with IDegLira →	OR (95% CI)	P value
Hypoglycemia <70 mg/dL	26%	48%	0.20.5125	0.39 (0.19–0.78)	P = 0.008
			0.20.5125Odds ratio (log scale)

Original publication

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. Diabetes Care. Published 17 July 2023. doi:10.2337/dc22-2426

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