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Randomized Controlled Trial
. 2020 Jun;43(6):1242-1248.
doi: 10.2337/dc19-1940. Epub 2020 Apr 9.

A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial

Francisco J Pasquel  1 , M Cecilia Lansang  2 , Ameer Khowaja  3 , M Agustina Urrutia  1 , Saumeth Cardona  1 , Bonnie Albury  1 , Rodolfo J Galindo  1 , Maya Fayfman  1 , Georgia Davis  1 , Alexandra Migdal  1 , Priyathama Vellanki  1 , Limin Peng  4 , Guillermo E Umpierrez  5
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Randomized Controlled Trial

A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial

Francisco J Pasquel et al. Diabetes Care. 2020 Jun.

Abstract

Objective: The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D.

Research design and methods: This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA1c 9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 (n = 92) or glargine U100 (n = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70-180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia.

Results: There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74). There were no differences in the proportion of patients with BG <70 mg/dL (8.7% vs. 9.5%, P > 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia (<54 mg/dL) compared with glargine U100 (0% vs. 6.0%, P = 0.023).

Conclusions: Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.

Trial registration: ClinicalTrials.gov NCT03013985.

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Figures

Figure 1
Figure 1
Study flow. LOS, length of stay.
Figure 2
Figure 2
Mean daily BG concentrations measured in patients treated with glargine U300 or glargine U100. Data are mean ± SD.
Figure 3
Figure 3
Proportion of patients with hypoglycemic episodes by POC testing.
See this image and copyright information in PMC

References

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