Glargine U300 Hospital Trial

Study Overview
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Brief Summary
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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
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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 .

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Glargine U300
* Drug: Glargine U100
* Drug: Glulisine Insulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood glucose