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

Completed · Phase 4

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT03336528

Run by

Emory University

People needed

180

Starts

2018-01-02

Expected to finish

2021-03-01

Last updated by the study team

2022-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females > 18 years of age who are admitted to a general medicine or surgical service
• 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
• Subjects with diet alone and HbA1c>7.0%
• Medical and surgical patients expected to be admitted length of stay (LOS) longer than 2 days
• 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)
• Signed, informed consent and HIPAA documentation prior to any study procedures

You may not qualify if…

• Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia)
• Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%
• Admission or pre-randomization BG≥400 mg/dL
• Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria
• Patients treated with degludec or glargine U300, or with long-acting weekly GLP-1 RA (weekly exenatide, dulaglutide or albiglutide)
• 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)
• 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)
• 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
• Known or suspected allergy to trial medication(s), excipients, or related products
• Previous participation in this trial

Where it is running

• Grady Hospital — Atlanta, Georgia, United States
• Emory University Hospital Clinical Research Network — Atlanta, Georgia, United States
• Mount Sinai — New York, New York, United States
• Providence Medical Research Centre — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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