The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperglycemia; Diabetes Mellitus
Intervention: Active Comparator: Glargine/Lispro insulin (Drug); Glargine/Lispro/NPH insulin arm (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s): Glenn R Cunningham, MD, Principal Investigator, Affiliation: Baylor College of Medicine
Overall contact: Glenn R Cunningham, MD, Phone: 832-355-7208, Email: glennc@bcm.edu
Summary
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.
Clinical Details
Official title: The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: The incidence of hyperglycemia (mean daily FSG >180 mg/dL) with the two regimens.The incidence of hypoglycemia (FSG < 70 mg/dL) with the two regimens.
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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:
-
Locations and Contacts
Glenn R Cunningham, MD, Phone: 832-355-7208, Email: glennc@bcm.edu
St. Luke's Episcopal Hospital, Houston, Texas 77030, United States; Recruiting Glenn R Cunningham, MD, Phone: 832-355-7208, Email: glennc@bcm.edu Glenn R Cunningham, MD, Principal Investigator Shadi Abdelnour, MD, Sub-Investigator Diana Engineer, MD, Sub-Investigator
Additional Information
Related publications: Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR. Review. Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8.
Starting date: September 2010
Last updated: March 12, 2013
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