Clinical trial NCT03013985: Glargine U300 Hospital Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Blood glucose
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 .

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.

Primary outcomes:
measure: Mean Daily Blood Glucose Concentration Inpatient
timeFrame: up to 10 days (day of hospital discharge)
measure: Mean Daily Blood Glucose Concentration After Hospital Discharge
timeFrame: assessed from day 11 (day after hospital discharge) up to 3 months
Secondary outcomes:
measure: Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%
timeFrame: up to 3 months post enrollment
measure: Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%
timeFrame: up to 3 months post enrollment
measure: Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days
timeFrame: Up to 3 days
measure: Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days
timeFrame: Up to 5 days
measure: Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days
timeFrame: Up to 10 days
measure: Percent of Blood Glucose 70-180 Measured by Point of Care Test
timeFrame: 3 months post enrollment
measure: Percent of Subjects With Hypoglycemic Events
timeFrame: 3 months post enrollment
measure: Percent of Subjects With Severe Hypoglycemia
timeFrame: 3 months post enrollment
measure: Number of Days of Hospital Stay
timeFrame: Up to 10 days
measure: Number Subjects With Cardiac Complications
timeFrame: 3 months post enrollment
measure: Number of Patients With Acute Renal Failure
timeFrame: 3 months post enrollment
measure: Hospital Mortality
timeFrame: During hospital stay - up to 10 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pasquel FJ, Lansang MC, Khowaja A, Urrutia MA, Cardona S, Albury B, Galindo RJ, Fayfman M, Davis G, Migdal A, Vellanki P, Peng L, Umpierrez GE. A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial. Diabetes Care. 2020 Jun;43(6):1242-1248. doi: 10.2337/dc19-1940. Epub 2020 Apr 9.