Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Degludec; Glargine; Aspart
Intervention description: Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner blood glucose (BG) between 100 mg/dL and 180 mg/dL.; Glargine is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner BG between 100 mg/dL and 180 mg/dL.; Aspart insulin will be given in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, aspart insulin dose will be held.
Intervention MeSH terms: Insulin Glargine; Insulin Aspart
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Long-acting insulin analog

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 to home after discharge from the
      hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females > 18 years of age who are 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 glucagon-like peptide-1 receptor
             agonists (GLP-1 RA) or insulin therapy except for degludec and glargine U300

          3. Subjects with diet alone and HbA1c>7.0%

          4. Medical and surgical patients expected to be admitted length of stay (LOS) longer than
             2 days

          5. Subjects must have a randomization BG > 140 mg and < 400 mg/dL without laboratory
             evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalent (mEq)/L, potential
             of hydrogen (pH) < 7.30, or positive serum or urinary ketones)

          6. 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. Admission or pre-randomization BG≥400 mg/dL

          4. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state,
             or ketonuria

          5. Patients treated with degludec or glargine U300, or with long-acting weekly GLP-1 RA
             (weekly exenatide, dulaglutide or albiglutide)

          6. Patients with acute critical or surgical illness admitted to the ICU except for
             observation (<24 hours and did not require vasopressors and/or mechanical ventilation)

          7. 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)

          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