Glargine U300 Hospital Trial



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:May 17, 2017
End Date:March 22, 2019

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A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes

The purpose of this study is to find out if treatment with Glargine U300 when compared to
Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D),
who are admitted to the hospital and then transition at home, after discharge from the
hospital.

Several randomized clinical trials done previously in medicine and surgical patients with T2D
have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose
(BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in
lower rate of hospital complications. Glargine U300 results in similar improvement but in
lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however,
have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and
diabetes in the hospital setting. This study will determine if treatment with glargine U300
has a similar glucose control in patients with diabetes admitted to the hospital and if
glargine U300 will result in lower number of low blood sugars compared to glargine U100 .

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.
We found this trial at
4
sites
80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Phone: 404-778-1665
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-778-1665
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: M. C Lansang, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Minneapolis, Minnesota 55414
Principal Investigator: Ameer Khowaja, MD
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Minneapolis, MN
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