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

Launched by EMORY UNIVERSITY · Nov 6, 2017

Keywords

ClinConnect Summary

Degludec is a new generation basal insulin analog with a longer duration of action compared to insulin glargine. 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 on or transitioned to this new insulin formulation so ...

Gender

ALL

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