Phase 4 N=37 Randomized Treatment

The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients

Hyperglycemia · Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT01810952 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

Jan 2017

Primary outcome: Primary: Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol. — 181.8; 173.7; 160.5; 148.4 mg/dL — p=0.35

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Glargine insulin (Drug); Lispro insulin (Drug); NPH Insulin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.	181.8; 173.7; 160.5; 148.4; 155.1; 140.8	0.35
SECONDARY Percent of Participants With Average Glucose >70 and <180 mg/dL	90; 94	0.65
SECONDARY Daily Insulin Dose/Kg Body Weight	0.89; 0.80; 0.91; 0.82; 0.96; 0.77	0.06
SECONDARY Glucose Values <70 mg/dL.	5; 4; 4; 2; 1; 0	0.795

Summary

The investigators hypothesize 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.

Eligibility Criteria

Inclusion Criteria

Admission for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
Treatment with pharmacological doses of glucocorticoids (GCs) ≥10 mg of prednisone or its equivalent if they are not on maintenance dose of GCs in the outpatient settings.
Treatment with pharmacological doses of GCs ≥10 mg of prednisone or its equivalent above their maintenance dose of GCs 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

Unwilling to sign informed consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01810952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.