Status:
COMPLETED
Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes
Lead Sponsor:
Emory University
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
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 compara...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03336528
Start Date
January 2 2018
End Date
March 1 2021
Last Update
March 31 2022
Active Locations (4)
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1
Grady Hospital
Atlanta, Georgia, United States, 30308
2
Emory University Hospital Clinical Research Network
Atlanta, Georgia, United States, 30322
3
Mount Sinai
New York, New York, United States, 10029
4
Providence Medical Research Centre
Spokane, Washington, United States, 99204