Glargine U300 Hospital Trial

Several randomized clinical trials done previously in medicine and surgical patients with T2D
have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose
(BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in
lower rate of hospital complications. Glargine U300 results in similar improvement but in
lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however,
have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and
diabetes in the hospital setting. This study will determine if treatment with glargine U300
has a similar glucose control in patients with diabetes admitted to the hospital and if
glargine U300 will result in lower number of low blood sugars compared to glargine U100 .

Inclusion Criteria:

- Males or females between > 18 years admitted to a general medicine or surgical
service.

- Known histories of T2D treated with either diet alone, oral monotherapy, any
combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide)
or insulin therapy with the exception of degludec and glargine U300.

- Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without
laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or
positive serum or urinary ketones).

Exclusion Criteria:

- Subjects with increased BG concentration, but without a known history of diabetes.

- Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA
(weekly exenatide, dulaglutide or albiglutide).

- Patients with acute critical or surgical illness admitted to the ICU or expected to
require admission to the ICU.

- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and
portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30
ml/min).

- Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study.

- Female subjects who are pregnant or breast feeding at time of enrollment into the
study.