Trial record 2 of 910 for:    Open Studies | "Insulin"

Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia (PTHG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Vancouver General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
David E. Harris, MD, Vancouver General Hospital
ClinicalTrials.gov Identifier:
NCT01648218
First received: July 12, 2012
Last updated: October 17, 2012
Last verified: July 2012
  Purpose

No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective:

  • Group 1: Intermediate-acting (NPH) insulin at breakfast
  • Group 2: Short-acting insulin (regular or aspart) before meals
  • Group 3: Insulin glargine at breakfast

Question/Hypothesis:

Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?


Condition Intervention Phase
Post-Transplant Glucocorticoid Induced Diabetes
Drug: Neutral protamine hagedorn (NPH) insulin
Drug: Regular human insulin or Insulin Aspart
Drug: Insulin glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

Resource links provided by NLM:


Further study details as provided by Vancouver General Hospital:

Primary Outcome Measures:
  • Blood glucose - inpatient [ Time Frame: Time (days) from enrollment to described treatment range, an expected average of 7 days ] [ Designated as safety issue: No ]
    Mean time from baseline to achieve at least 80% of pre-meal capillary blood glucose values within 5.0 - 7.8 mmol/L over a 48 hour period during hospitalization


Secondary Outcome Measures:
  • Blood glucose - inpatient [ Time Frame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days ] [ Designated as safety issue: No ]
    Mean inpatient capillary blood glucose (mmol/L) from enrollment to discharge from hospital

  • Post prandial blood glucose - inpatient [ Time Frame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days ] [ Designated as safety issue: No ]
    Mean inpatient two-hour post-lunch capillary blood glucose (mmol/L) from enrollment to discharge from hospital

  • Length of inpatient hospital stay [ Time Frame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days ] [ Designated as safety issue: No ]
    Length of stay in hospital (days) from enrollment to discharge from hospital

  • Blood glucose [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: No ]
    Mean fasting blood glucose (mmol/L) from enrollment to 3 months

  • Hemoglobin A1C [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: No ]
    Mean hemoglobin A1C (%) from enrollment to 3 months

  • Post prandial blood glucose [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: No ]
    Mean two-hour post-lunch capillary blood glucose (mmol/L) from enrollment to 3 months

  • Hypoglycemic episodes [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: Yes ]

    Hypoglycemic episodes defined as:

    (1) Mild - any measured CBG 3.0-4.0 mmol/L; (2) Severe - any episode of hypoglycemia with a measured CBG < 3.0 mmol/L, OR which the subject is not able to recognize and treat without the direct (substantial) intervention of a professional caregiver, nurse or physician (e.g. intravenous dextrose or intramuscular glucagon)


  • Glycemic treatment failure [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: Yes ]

    Hypoglycemic treatment failure: subject experiences ≥3 hypoglycemic episodes (≤ 4.0 mmol/L) over any 5 day period or a single severe hypoglycemic event (as previously defined), they will be withdrawn from study and managed at discretion of attending physician, or hospital endocrine consult service.

    Hyperglycemic treatment failure: Severe hyperglycemia defined as CBG >20 mmol/L. If subject experiences ≥3 severe hyperglycemic measures over the course of 48 hours they will be withdrawn from the study and managed at discretion of attending physician, or hospital endocrine consult service.


  • Cardiovascular events [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: No ]
    New cardiovascular events defined as: myocardial infarction, new or worsened congestive heart failure, stroke, and cardiac arrhythmia.

  • Post-transplant infections or new antibiotic use [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: No ]
    Post-transplant infections or new antibiotic use from enrollment to 3 months.

  • Transplant graft failure [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: No ]
    Transplant graft failure (as specified by subject's medical transplant physician) from enrollment to 3 months.

  • New acute renal failure [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: No ]
    New acute renal failure is defined according to Acute Kidney Network Guidelines: rapid time course and decreased kidney function according to an absolute Creatinine (Cr) rise greater than 26 μmol/L, greater than 2-fold increase in serum Cr from baseline, or urine output less than 0.5 mL/kg/hr for greater than 6 hours

  • Mortality [ Time Frame: Enrollment to 3 months ] [ Designated as safety issue: No ]
    Overall subject mortality from baseline to 3 months.


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neutral protamine hagedorn (NPH) insulin

Drug: Neutral protamine hagedorn (NPH) insulin

Other Names:

Humulin N, Novolin N

Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before breakfast; Duration: 12 hours; for duration subjects are concurrently administered once-daily glucocorticoid.

Drug: Neutral protamine hagedorn (NPH) insulin
Other Name: Humulin N, Novolin N
Experimental: Regular or Aspart insulin

Drug: Regular human insulin or Insulin Aspart

Other Names:

Humulin R, Novolin R, Novolog, NovoRapid

Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before meals; Duration: 2 hours (Aspart) or 6 hours (Regular); for duration subjects are concurrently administered once-daily glucocorticoid.

Drug: Regular human insulin or Insulin Aspart
Other Names:
  • Humulin R
  • Novolin R
  • Novolog
  • NovoRapid
Experimental: Insulin glargine

Drug: Insulin glargine

Other Names:

Lantus

Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before breakfast; Duration: 24 hours; for duration subjects are concurrently administered once-daily glucocorticoid.

Drug: Insulin glargine
Other Name: Lantus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have undergone bone marrow, liver, lung, or renal transplant.
  2. Be using once daily oral glucocorticoid therapy (total daily dose of Prednisone ≥10 mg, Hydrocortisone ≥40 mg, Dexamethasone ≥1.5 mg) administered in the morning and expected to continue for at least 2 weeks.
  3. Have pre-existing or newly diagnosed diabetes mellitus established by any of the criteria listed below:

    1. Fasting plasma glucose ≥7.0 mmol/L (repeated x 1)
    2. Any plasma glucose ≥11.0 mmol/L
  4. Have at least three pre-meal inpatient capillary blood glucose (CBG) readings ≥ 7.8 mmol/L
  5. Be eating meals by mouth

Exclusion Criteria:

  1. Heart, Pancreas, Islet cell transplant recipients
  2. Previous use of Basal-Bolus or Pre-Mixed Insulin regimen
  3. Diabetes mellitus type I
  4. NPO (not eating meals by mouth)
  5. Receiving enteral (tube feeds) or parenteral (TPN) nutrition
  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: NCT01648218

Contacts
Contact: Breay W Paty, MD, FRCPC 604-875-5990 breay.paty@vch.ca
Contact: David E Harris, MD, FRCPC 778-995-5414 deharris@interchange.ubc.ca

Locations
Canada, British Columbia
Vancouver General Hospital - Jim Pattison Pavilion Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Breay W Paty, MD, FRCPC    604-875-5990    breay.paty@vch.ca   
Contact: David E Harris, MD, FRCPC    778-995-5414    deharris@interchange.ubc.ca   
Principal Investigator: Breay W Paty, MD, FRCPC         
Sponsors and Collaborators
Vancouver General Hospital
Investigators
Principal Investigator: Breay W Paty, MD, FRCPC Vancouver General Hospital, University of British Columbia
  More Information

Additional Information:
Publications:
Responsible Party: David E. Harris, MD, MD, FRCPC, Clinical Endocrinology Fellow, University of British Columbia, Vancouver General Hospital
ClinicalTrials.gov Identifier: NCT01648218     History of Changes
Other Study ID Numbers: PTHG.VGH.UBC
Study First Received: July 12, 2012
Last Updated: October 17, 2012
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Vancouver General Hospital:
glucocorticoid
diabetes mellitus
post-transplant
insulin

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Insulin Aspart
Insulin, Long-Acting
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucocorticoids
Glargine
Protamines
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014