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Completed

NCT Number: NCT03013985

Glargine U300 Hospital Trial

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University, Atlanta, Georgia, United States

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glargine U300

Drug

Glargine U300 is a new generation long-acting insulin.

Other names: Toujeo

Glargine U100

Drug

Glargine U100 is a long-acting insulin.

Other names: Lantus

Glulisine Insulin

Drug

Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.

Other names: Apidra

Primary outcomes

  1. Mean Daily Blood Glucose Concentration Inpatient

    Time frame: up to 10 days (day of hospital discharge)

    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.

  2. Mean Daily Blood Glucose Concentration After Hospital Discharge

    Time frame: assessed from day 11 (day after hospital discharge) up to 3 months

    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 outcomes

  1. Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%

    Time frame: up to 3 months post enrollment

    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.

  2. Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%

    Time frame: up to 3 months post enrollment

    Mean daily blood glucose concentration for subjects with HbA1c higher than 8% at admission will be recorded

  3. Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days

    Time frame: Up to 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

  4. Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days

    Time frame: Up to 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

  5. Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days

    Time frame: Up to 10 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.

  6. Percent of Blood Glucose 70-180 Measured by Point of Care Test

    Time frame: 3 months post enrollment

    Percent of Blood Glucose Readings in the 70-180 mg/dL Range Measured by Point of Care Test

  7. Percent of Subjects With Hypoglycemic Events

    Time frame: 3 months post enrollment

    Percent of of subjects with hypoglycemic events (BG < 70 mg/dl) will be recorded.

  8. Percent of Subjects With Severe Hypoglycemia

    Time frame: 3 months post enrollment

    Percent of subjects experiencing severe hypoglycemia (BG <54 mg/dl) will be recorded.

  9. Number of Days of Hospital Stay

    Time frame: Up to 10 days

    The number of days of hospital stay for each subject will be recorded.

  10. Number Subjects With Cardiac Complications

    Time frame: 3 months post enrollment

    The number of subjects experiencing cardiac cardiac complications will be recorded.

  11. Number of Patients With Acute Renal Failure

    Time frame: 3 months post enrollment

    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).

  12. Hospital Mortality

    Time frame: During hospital stay - up to 10 days

    Number of hospital deaths that occur.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2017
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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