Glargine U300 Hospital Trial

Type 2 Diabetes Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013985
• Other study ID #: IRB00091740
• Status: Completed
• Phase: Phase 4
• Start date: May 17, 2017
• Est. completion date: March 22, 2019

Study information

• Verified date: April 2020
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Glargine U300
Glargine U300 is a new generation long-acting insulin.
• Glargine U100
Glargine U100 is a long-acting insulin.
• Glulisine Insulin
Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percent of Subjects With Hypoglycemic Events	Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.	3 months post enrollment
Secondary	Percent of Subjects With Severe Hypoglycemia	Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.	3 months post enrollment
Secondary	Number of Days of Hospital Stay	The number of days of hospital stay for each subject will be recorded.	Up to 10 days
Secondary	Number Subjects With Cardiac Complications	The number of subjects experiencing cardiac cardiac complications will be recorded.	3 months post enrollment
Secondary	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
Secondary	Hospital Mortality	Number of hospital deaths that occur.	During hospital stay - up to 10 days