Glargine U300 Hospital Trial
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Blood glucose
Eligibility Criteria
Inclusion Criteria:
- Males or females between > 18 years admitted to a general medicine or surgical service.
- Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U300.
- Subjects must have an admission/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).
Exclusion Criteria:
- Subjects with increased BG concentration, but without a known history of diabetes.
- Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide).
- Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min).
- 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.
Sites / Locations
- Grady Memorial Hospital
- Emory University
- Hennepin County Medical Center
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Basal bolus insulin with glargine U300 and glulisine insulin
Basal bolus insulin with glargine U100 and glulisine insulin
Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.