This prospective, open-label, randomized clinical trial compared the safety and efficacy of a basal bolus regimen using glargine U300 or glargine U100 for the management of general medicine and surgery patients with T2D. A total of 171 patients (age: 57±12 years, admission BG: 229±82 mg/dl and HbA1c: 9.5±2.2% [mean±SD]), treated with oral agents or insulin prior to admission, were randomized to glargine U300 (n=90) or glargine U100 (n=81). Total daily dose (TDD) started at 0.4 U/kg/d for BG: 140-200 mg/dl or 0.5 U/kg/d for BG: 201-400 mg/dl. Half of TDD was given as glargine U300 or U100 once daily and half as glulisine before meals. We adjusted insulin daily to a target BG: 70-180 mg/dl. We measured BG by capillary point of care (POC) testing before meals and bedtime. To further examine glucose differences, we placed a professional Freestyle Libre CGM in a subgroup of patients (n=82). Major outcomes included differences in mean daily BG and frequency of hypoglycemia between groups. There were no differences between glargine U300 and U100 in mean daily BG (POC: 188 ±41vs. 184±45 mg/dl, p=0.47; CGM: 172±45 vs. 165±47 mg/dl, p=0.42), percentage (%) of glucose readings between 70-180 mg/dl (POC: 50±25% vs. 52±27%, p=0.74; CGM: 55±26% vs. 56±27%, p=0.80), length of stay (median (IQR): 6.0 (4.0-8.0) vs. 4.0 (3.0, 7.0) days, p=0.07), hospital complications (6.7% vs. 11%, p=0.42), or insulin TDD (0.44±0.21 vs. 0.43±0.20 U/kg/day, p=0.74). There were no differences % of BG <70 mg/dl (POC: 0.62±2.51 vs. 0.82±2.98, p>0.99; CGM: 5.88±14.49 vs. 5.74±8.15, p= 0.35), but U300 resulted in significant lower rates of BG <54 mg/dl (POC: 0% vs. 0.45±2.45, p=0.033, CGM: 0.82±1.39 vs. 2.18±4.16 p=0.23).
In summary, our study indicates that hospital treatment with glargine U300 resulted in similar glycemic control and lower frequency of clinically significant hypoglycemia compared to glargine U100 in general medicine and surgery patients with T2D.
F.J. Pasquel: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc. M. Lansang: None. A. Khowaja: None. R.J. Galindo: Advisory Panel; Self; Abbott, Novo Nordisk Inc., Sanofi US. Research Support; Self; Novo Nordisk Inc. M.A. Urrutia: None. S. Cardona: None. A. Shakally: None. R.C. Lyerla: None. I. Anzola: None. B.S. Albury: None. J. Haw: None. M. Fayfman: None. G. Davis: None. A. Migdal: None. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc. Research Support; Self; National Institutes of Health. L. Peng: None. G.E. Umpierrez: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc. Research Support; Self; AstraZeneca, Merck & Co., Inc., Novo Nordisk Inc., Sanofi US.