The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients (GIH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Glenn R. Cunningham, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01810952
First received: March 11, 2013
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

The investigators hypothesize that formula that includes patient weight and glucocorticoid dose can be used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be treated with pharmacological doses of glucocorticoids.


Condition Intervention Phase
Hyperglycemia
Diabetes Mellitus
Drug: Active Comparator: Glargine/Lispro insulin
Drug: Glargine/Lispro/NPH insulin arm
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Average daily glucose levels in patients treated with glargine and lispro (G/L) versus glargine, lispro and NPH (G/L/N) on days 2-5 after the initiation of the treatment protocol. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of hyperglycemia (mean daily FSG >180 mg/dL) with the two regimens. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
  • The incidence of hypoglycemia (FSG < 70 mg/dL) with the two regimens. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • The management of glucocorticoid-induced hyperglycemia in hospitalized patients. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Determine the total daily dose of insulin required based on weight and GC dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL

  • The management of glucocorticoid-induced hyperglycemia in hospitalized patients. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Assess the usefulness of HbA1c, BMI, fasting glucose or duration of diabetes (if present) as independent predictors of glycemic control.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glargine/Lispro insulin Arm
The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Drug: Active Comparator: Glargine/Lispro insulin

In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL.

If the patient had an outpatient regimen which includes a total daily dose of insulin (TDI) that exceeds 0.4 unit/kg/day, then the same TDI will be continued with 50% given as glargine once daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; and 50% given as lispro divided between three meals. The patient will still be randomly assigned to either one of the two protocols as described previously.

Other Names:
  • glargine insulin
  • lispro insulin
Experimental: Glargine/Lispro/NPH insulin Arm
The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Drug: Glargine/Lispro/NPH insulin arm
The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.
Other Names:
  • Glargine insulin
  • Lispro insulin
  • NPH insulin

Detailed Description:

The target fasting and pre-meal FSG will be 90-140 mg/dL, and the random FSG will be less than180 mg/dL, taking into consideration the ADA/AACE target glucose levels in non-ICU patients (15).

The G/L Protocol will include 0.2 unit/kg/day as insulin glargine once daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting "coverage" dose will be 0.4 units/kg per day.

The prandial dose of lispro will be increased by 10% if the pre-lunch, pre-dinner, or bedtime FSG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime FSG is >200 mg/dL. The prandial dose of lispro will be decreased by 10% if the pre-lunch, pre-dinner, or bedtime FSG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime FSG is less than 70 mg/dL.

The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine once daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose will be 0.4 units/kg per day.

The NPH dose will be increased by 10% if the pre-lunch, pre-dinner, or bedtime FSG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime FSG is greater than 200 mg/dL. The NPH dose will be decreased by 10% if the pre-lunch, pre-dinner, or bedtime FSG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime FSG is less than 70 mg/dL.

In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL.

If the patient had an outpatient regimen which includes a total daily dose of insulin (TDI) that exceeds 0.4 unit/kg/day, then the same TDI will be continued with 50% given as glargine once daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; and 50% given as lispro divided between three meals. The patient will still be randomly assigned to either one of the two protocols as described previously.

If the patient were on a TDI less than 0.4 unit/kg/day in addition to oral antidiabetic medications as an outpatient, then all the oral antidiabetic medications will be discontinued and the patient will be started on 0.5 unit/kg/day divided as 50% glargine given once daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; and 50% lispro divided between three meals. The patient will still be randomly assigned to either one of the two protocols based upon even and odd hospital numbers.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission for COPD exacerbation.
  • Treatment with pharmacological doses of GC's ≥10 mg of prednisone or its equivalent if they are not on maintenance dose of GC's in the outpatient settings.
  • Treatment with pharmacological doses of GC's ≥10 mg of prednisone or its equivalent above their maintenance dose of GC's in the outpatient settings.
  • Have either a previous diagnosis of diabetes mellitus which has been treated with diet or medications, hemoglobin A1c ≥6.5%, or confirmed inpatient hyperglycemia defined as a fasting laboratory glucose or finger stick reading ≥126 mg/dL or random glucose reading ≥200 mg/dL on two or more determinations.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810952

Contacts
Contact: Glenn R Cunningham, MD 832-355-7208 glennc@bcm.edu

Locations
United States, Texas
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Glenn R Cunningham, MD    832-355-7208    glennc@bcm.edu   
Principal Investigator: Glenn R Cunningham, MD         
Sub-Investigator: Shadi Abdelnour, MD         
Sub-Investigator: Diana Engineer, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Glenn R Cunningham, MD Baylor College of Medicine
  More Information

Publications:
Responsible Party: Glenn R. Cunningham, Professor of Medicine and Molecular & Cellular Biology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01810952     History of Changes
Other Study ID Numbers: H-27172
Study First Received: March 11, 2013
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
glucocorticoids
hyperglycemia
diabetes mellitus

Additional relevant MeSH terms:
Hyperglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucocorticoids
Insulin LISPRO
Glargine
Insulin
Insulin, NPH
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 28, 2014