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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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.