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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

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posted on 09.04.2020 by Francisco J. Pasquel, M. Cecilia Lansang, Ameer Khowaja, M. Agustina Urrutia, Saumeth Cardona, Bonnie Albury, Rodolfo J. Galindo, Maya Fayfman, Georgia Davis, Alexandra Migdal, Priyathama Vellanki, Limin Peng, Guillermo E. Umpierrez
Background: 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 vs. glargine U100 in non-critically ill patients with T2D.

Methods: This prospective, open-label, randomized clinical trial included 176 poorly controlled patients with T2D (admission blood glucose (BG): 228±82 mg/dl and HbA1c: 9.5±2.2%), treated with oral agents or insulin prior to 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: 70-180 mg/dl. The primary endpoint was non-inferiority in 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 TDD (0.43±0.21 vs 0.42±0.20 U/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 to glargine U100 (0% vs 6.0%, p=0.023).

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

Funding

The study was an investigator-initiated study funded by Sanofi. The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report.

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