Glargine U300 Hospital Trial

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Glargine U300; Drug: Glulisine Insulin; Drug: Glargine U100

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 .

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basal bolus insulin with glargine U300 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.	Drug: Glargine U300; Glargine U300 is a new generation long-acting insulin.; Other Names: Toujeo; Drug: Glulisine Insulin; Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.; Other Names: Apidra
Active Comparator: 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 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.	Drug: Glulisine Insulin; Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.; Other Names: Apidra; Drug: Glargine U100; Glargine U100 is a long-acting insulin.; Other Names: Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Daily Blood Glucose Concentration Inpatient	The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.	up to 10 days (day of hospital discharge)
Mean Daily Blood Glucose Concentration After Hospital Discharge	Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.	assessed from day 11 (day after hospital discharge) up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%	Glycemic control will be measured by mean daily blood glucose concentration for subjects with HbA1c lower than 8% at admission. The average of all pre-meal and bedtime glucose values will be calculated.	up to 3 months post enrollment
Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%	Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded	up to 3 months post enrollment
Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days	Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days	Up to 3 days
Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days	Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days	Up to 5 days
Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days	Glycemic control will be measured by mean daily blood glucose concentration for subjects with length of hospital stay longer than 5 days. The average of daily pre-meal and bedtime glucose values will be calculated.	Up to 10 days
Percent of Blood Glucose 70-180 Measured by Point of Care Test	Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test	3 months post enrollment
Percent of Subjects With Hypoglycemic Events	Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.	3 months post enrollment
Percent of Subjects With Severe Hypoglycemia	Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.	3 months post enrollment
Number of Days of Hospital Stay	The number of days of hospital stay for each subject will be recorded.	Up to 10 days
Number Subjects With Cardiac Complications	The number of subjects experiencing cardiac cardiac complications will be recorded.	3 months post enrollment
Number of Patients With Acute Renal Failure	The number of subjects with a clinical diagnosis with documented new-onset abnormal renal function (increment in serum creatinine > 0.5 mg/dL from baseline).	3 months post enrollment
Hospital Mortality	Number of hospital deaths that occur.	During hospital stay - up to 10 days

Collaborators and Investigators

• Sponsor: Emory University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): March 22, 2019
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Blood glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine; Insulin glulisine
• Other Study ID Numbers: IRB00091740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No