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Glargine U300 Hospital Trial

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glargine U300
Glargine U100
Glulisine Insulin
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Basal bolus insulin with glargine U300 and glulisine insulin

Basal bolus insulin with glargine U100 and glulisine insulin

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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
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
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.
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
Percent of Subjects With Hypoglycemic Events
Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.
Percent of Subjects With Severe Hypoglycemia
Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.
Number of Days of Hospital Stay
The number of days of hospital stay for each subject will be recorded.
Number Subjects With Cardiac Complications
The number of subjects experiencing cardiac cardiac complications will be recorded.
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).
Hospital Mortality
Number of hospital deaths that occur.

Full Information

First Posted
January 5, 2017
Last Updated
April 23, 2020
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03013985
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Blood glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basal bolus insulin with glargine U300 and glulisine insulin
Arm Type
Experimental
Arm Description
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.
Arm Title
Basal bolus insulin with glargine U100 and glulisine insulin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glargine U300
Other Intervention Name(s)
Toujeo
Intervention Description
Glargine U300 is a new generation long-acting insulin.
Intervention Type
Drug
Intervention Name(s)
Glargine U100
Other Intervention Name(s)
Lantus
Intervention Description
Glargine U100 is a long-acting insulin.
Intervention Type
Drug
Intervention Name(s)
Glulisine Insulin
Other Intervention Name(s)
Apidra
Intervention Description
Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
Primary Outcome Measure Information:
Title
Mean Daily Blood Glucose Concentration Inpatient
Description
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.
Time Frame
up to 10 days (day of hospital discharge)
Title
Mean Daily Blood Glucose Concentration After Hospital Discharge
Description
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.
Time Frame
assessed from day 11 (day after hospital discharge) up to 3 months
Secondary Outcome Measure Information:
Title
Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%
Description
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.
Time Frame
up to 3 months post enrollment
Title
Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%
Description
Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded
Time Frame
up to 3 months post enrollment
Title
Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days
Description
Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 3 days
Time Frame
Up to 3 days
Title
Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days
Description
Glycemic control will be conducted by measuring mean daily blood glucose concentration for subjects with length of hospital stay shorter than 5 days
Time Frame
Up to 5 days
Title
Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days
Description
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.
Time Frame
Up to 10 days
Title
Percent of Blood Glucose 70-180 Measured by Point of Care Test
Description
Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test
Time Frame
3 months post enrollment
Title
Percent of Subjects With Hypoglycemic Events
Description
Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.
Time Frame
3 months post enrollment
Title
Percent of Subjects With Severe Hypoglycemia
Description
Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.
Time Frame
3 months post enrollment
Title
Number of Days of Hospital Stay
Description
The number of days of hospital stay for each subject will be recorded.
Time Frame
Up to 10 days
Title
Number Subjects With Cardiac Complications
Description
The number of subjects experiencing cardiac cardiac complications will be recorded.
Time Frame
3 months post enrollment
Title
Number of Patients With Acute Renal Failure
Description
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).
Time Frame
3 months post enrollment
Title
Hospital Mortality
Description
Number of hospital deaths that occur.
Time Frame
During hospital stay - up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Umpierrez, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32273271
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.
Results Reference
derived

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Glargine U300 Hospital Trial

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