The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients

NCT01810952 | Completed Phase 4 Results

• 1 other identifier: H-27172
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperglycemia; Diabetes Mellitus

Keywords

glucocorticoids; hyperglycemia; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.

  Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."

  1-5 days

Secondary Outcomes (3)

• Percent of Participants With Average Glucose >70 and <180 mg/dL

  Last Full Day of Protocol for Participant (up to Day 5)

• Daily Insulin Dose/Kg Body Weight

  1-5 days

• Glucose Values <70 mg/dL.

  1-5 days

Study Arms (2)

Glargine/Lispro Insulin Arm

EXPERIMENTAL

Drug: Glargine insulin was administered per above. Drug: Lispro insulin 0.2 unit/kg/day was administered per above. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day. The prandial dose of lispro was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG is \>200 mg/dL. The prandial dose of lispro was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL. Drug: prednisone or equivalent dose was determined by severity of exacerbation and clinician's judgement.

Drug: Glargine insulin; Drug: Lispro insulin

Glargine/Lispro/NPH Insulin Arm

EXPERIMENTAL

Drugs Glargine and Lispro insulin included similar starting doses of glargine and lispro. Drug: A "coverage" dose of NPH insulin 0.1 unit/kg/day for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. Maximum starting "coverage" dose was 0.4 units/kg per day. NPH dose was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was greater than 200 mg/dL. It was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL. Drug: the dose of prednisone or equivalent glucocorticoid was determined by severity of exacerbation and clinician's judgement.

Drug: Glargine insulin; Drug: Lispro insulin; Drug: NPH Insulin

Interventions

Glargine insulin DRUG

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

Glargine/Lispro Insulin Arm; Glargine/Lispro/NPH Insulin Arm

Lispro insulin DRUG

In both protocols lispro insulin was given to cover meals. Additional lispro insulin was Lispro insulin was administered before meals to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro Insulin Arm.

Glargine/Lispro Insulin Arm; Glargine/Lispro/NPH Insulin Arm

NPH Insulin DRUG

NPH insulin was given once or twice a day to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro/NPH Insulin Arm

Glargine/Lispro/NPH Insulin Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unwilling to sign informed consent.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR.

  PMID: 19454391 BACKGROUND

• 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. No abstract available.

  PMID: 19429873 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus

Interventions

Insulin Glargine; Insulin Lispro; Insulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Limitations and Caveats

The number of participants is limited, and some were discharged in less than 5 days.

Results Point of Contact

• Title: Professor of Medicine
• Organization: Baylor College of Medicine

glennc@bcm.edu

713-660-9902

Study Officials

• Glenn R Cunningham, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Molecular & Cellular Biology

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 14, 2013
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 8, 2017
• Results First Posted: January 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)