A Trial Comparing Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes

Several outpatient trials have reported that treatment with degludec results in comparable
improvement in HbA1c levels and in lower rates of hypoglycemia compared to glargine U100
insulin. However, no previous studies have compared the safety and efficacy of the
long-acting basal insulin degludec in the inpatient management of patients with diabetes. It
is expected that a large number of patients with diabetes will be started or transitioned to
this new insulin formulation; so acquiring knowledge on their safety and efficacy is of great
clinical interest. Accordingly, the proposed study will provide novel and clinically useful
information on the efficacy (blood glucose control) and safety (hypoglycemia) of degludec in
the inpatient setting and after hospital discharge in general medicine and surgery patients
with Type 2 Diabetes (T2D).

Inclusion Criteria:

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

2. A known history of T2D treated either with diet alone, oral monotherapy, any
combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide)
or insulin therapy except for degludec and glargine U300.

3. Medical and surgical patients expected to be admitted length of stay (LOS) longer than
3 days

4. Subjects must have a 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).

5. Signed, informed consent and HIPAA documentation prior to any study procedures

Exclusion Criteria:

1. Subjects with increased BG concentration, but without a known history of diabetes
(stress hyperglycemia).

2. Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%.

3. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state,
or ketonuria 32.

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

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

6. Patients with history of clinically relevant hepatic disease (diagnosed liver
cirrhosis and portal hypertension), ongoing corticosteroid therapy (equal to a
prednisone dose ≥5 mg/day), or impaired renal function (eGFR< 30 ml/min), or
congestive heart failure (NYHA- IV).

7. Patients with medical and surgical pancreatic disease.

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

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

10. Known or suspected allergy to trial medication(s), excipients, or related products.

11. Previous participation in this trial.