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

ID#: NCT03336528

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 4

Recruitment Status: Recruiting

Start Date: January 02, 2018

End Date: December 31, 2019

Contact Information:
Guillermo Umpierrez
Saumeth Cardona Bolivar, MD
Summary: The purpose of this study is to find out if treatment with Degludec insulin when compared to glargine U100 insulin will result in similar blood sugar control in patients with diabetes, who are admitted to the hospital and then transition at home, after discharge from the hospital.

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.