Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-03 @ 4:29 AM
Study NCT ID:
NCT01648218
Status:
TERMINATED
Last Update Posted:
2015-12-09
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'D000068880', 'term': 'Isophane Insulin, Human'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061386', 'term': 'Insulin, Regular, Human'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2012-07-12', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose - inpatient', 'timeFrame': 'Time (days) from enrollment to described treatment range, an expected average of 7 days', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Blood glucose - inpatient', 'timeFrame': 'Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days', 'description': 'Mean inpatient capillary blood glucose (mmol/L) from enrollment to discharge from hospital'}, {'measure': 'Post prandial blood glucose - inpatient', 'timeFrame': 'Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days', 'description': 'Mean inpatient two-hour post-lunch capillary blood glucose (mmol/L) from enrollment to discharge from hospital'}, {'measure': 'Length of inpatient hospital stay', 'timeFrame': 'Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days', 'description': 'Length of stay in hospital (days) from enrollment to discharge from hospital'}, {'measure': 'Blood glucose', 'timeFrame': 'Enrollment to 3 months', 'description': 'Mean fasting blood glucose (mmol/L) from enrollment to 3 months'}, {'measure': 'Hemoglobin A1C', 'timeFrame': 'Enrollment to 3 months', 'description': 'Mean hemoglobin A1C (%) from enrollment to 3 months'}, {'measure': 'Post prandial blood glucose', 'timeFrame': 'Enrollment to 3 months', 'description': 'Mean two-hour post-lunch capillary blood glucose (mmol/L) from enrollment to 3 months'}, {'measure': 'Hypoglycemic episodes', 'timeFrame': 'Enrollment to 3 months', 'description': 'Hypoglycemic episodes defined as:\n\n(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)'}, {'measure': 'Glycemic treatment failure', 'timeFrame': 'Enrollment to 3 months', 'description': '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.\n\nHyperglycemic 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.'}, {'measure': 'Cardiovascular events', 'timeFrame': 'Enrollment to 3 months', 'description': 'New cardiovascular events defined as: myocardial infarction, new or worsened congestive heart failure, stroke, and cardiac arrhythmia.'}, {'measure': 'Post-transplant infections or new antibiotic use', 'timeFrame': 'Enrollment to 3 months', 'description': 'Post-transplant infections or new antibiotic use from enrollment to 3 months.'}, {'measure': 'Transplant graft failure', 'timeFrame': 'Enrollment to 3 months', 'description': "Transplant graft failure (as specified by subject's medical transplant physician) from enrollment to 3 months."}, {'measure': 'New acute renal failure', 'timeFrame': 'Enrollment to 3 months', 'description': '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'}, {'measure': 'Mortality', 'timeFrame': 'Enrollment to 3 months', 'description': 'Overall subject mortality from baseline to 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glucocorticoid', 'diabetes mellitus', 'post-transplant', 'insulin'], 'conditions': ['Post-Transplant Glucocorticoid Induced Diabetes']}, 'referencesModule': {'references': [{'pmid': '22058376', 'type': 'BACKGROUND', 'citation': 'Lane JT, Dagogo-Jack S. Approach to the patient with new-onset diabetes after transplant (NODAT). J Clin Endocrinol Metab. 2011 Nov;96(11):3289-97. doi: 10.1210/jc.2011-0657.'}, {'pmid': '22475764', 'type': 'BACKGROUND', 'citation': 'Sarno G, Muscogiuri G, De Rosa P. New-onset diabetes after kidney transplantation: prevalence, risk factors, and management. Transplantation. 2012 Jun 27;93(12):1189-95. doi: 10.1097/TP.0b013e31824db97d.'}, {'pmid': '20439241', 'type': 'BACKGROUND', 'citation': 'Griffith ML, Jagasia M, Jagasia SM. Diabetes mellitus after hematopoietic stem cell transplantation. Endocr Pract. 2010 Jul-Aug;16(4):699-706. doi: 10.4158/EP10027.RA.'}, {'pmid': '22049542', 'type': 'BACKGROUND', 'citation': 'Lansang MC, Hustak LK. Glucocorticoid-induced diabetes and adrenal suppression: how to detect and manage them. Cleve Clin J Med. 2011 Nov;78(11):748-56. doi: 10.3949/ccjm.78a.10180.'}, {'pmid': '22223765', 'type': 'BACKGROUND', 'citation': 'Umpierrez GE, Hellman R, Korytkowski MT, Kosiborod M, Maynard GA, Montori VM, Seley JJ, Van den Berghe G; Endocrine Society. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012 Jan;97(1):16-38. doi: 10.1210/jc.2011-2098.'}], 'seeAlsoLinks': [{'url': 'http://www.diabetes.ca/diabetes-and-you/nutrition/just-basics/', 'label': 'Multilingual dietary instructions to be distributed to ALL subjects during study from the Canadian Diabetes Association'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Group 1: Intermediate-acting (NPH) insulin at breakfast\n* Group 2: Short-acting insulin (regular or aspart) before meals\n* Group 3: Insulin glargine at breakfast\n\nQuestion/Hypothesis:\n\nAmong three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have undergone bone marrow, liver, lung, or renal transplant.\n2. 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.\n3. Have pre-existing or newly diagnosed diabetes mellitus established by any of the criteria listed below:\n\n 1. Fasting plasma glucose ≥7.0 mmol/L (repeated x 1)\n 2. Any plasma glucose ≥11.0 mmol/L\n4. Have at least three pre-meal inpatient capillary blood glucose (CBG) readings ≥ 7.8 mmol/L\n5. Be eating meals by mouth\n\nExclusion Criteria:\n\n1. Heart, Pancreas, Islet cell transplant recipients\n2. Previous use of Basal-Bolus or Pre-Mixed Insulin regimen\n3. Diabetes mellitus type I\n4. NPO (not eating meals by mouth)\n5. Receiving enteral (tube feeds) or parenteral (TPN) nutrition'}, 'identificationModule': {'nctId': 'NCT01648218', 'acronym': 'PTHG', 'briefTitle': 'Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia', 'organization': {'class': 'OTHER', 'fullName': 'Vancouver General Hospital'}, 'officialTitle': 'Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia', 'orgStudyIdInfo': {'id': 'PTHG.VGH.UBC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neutral protamine hagedorn (NPH) insulin', 'description': 'Drug: Neutral protamine hagedorn (NPH) insulin\n\nOther Names:\n\nHumulin N, Novolin N\n\nRoute: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before breakfast; Duration: 12 hours; for duration subjects are concurrently administered once-daily glucocorticoid.', 'interventionNames': ['Drug: Neutral protamine hagedorn (NPH) insulin']}, {'type': 'EXPERIMENTAL', 'label': 'Regular or Aspart insulin', 'description': 'Drug: Regular human insulin or Insulin Aspart\n\nOther Names:\n\nHumulin R, Novolin R, Novolog, NovoRapid\n\nRoute: 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.', 'interventionNames': ['Drug: Regular human insulin or Insulin Aspart']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin glargine', 'description': 'Drug: Insulin glargine\n\nOther Names:\n\nLantus\n\nRoute: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before breakfast; Duration: 24 hours; for duration subjects are concurrently administered once-daily glucocorticoid.', 'interventionNames': ['Drug: Insulin glargine']}], 'interventions': [{'name': 'Neutral protamine hagedorn (NPH) insulin', 'type': 'DRUG', 'otherNames': ['Humulin N, Novolin N'], 'armGroupLabels': ['Neutral protamine hagedorn (NPH) insulin']}, {'name': 'Regular human insulin or Insulin Aspart', 'type': 'DRUG', 'otherNames': ['Humulin R', 'Novolin R', 'Novolog', 'NovoRapid'], 'armGroupLabels': ['Regular or Aspart insulin']}, {'name': 'Insulin glargine', 'type': 'DRUG', 'otherNames': ['Lantus'], 'armGroupLabels': ['Insulin glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital - Jim Pattison Pavilion', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Breay W Paty, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vancouver General Hospital, University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vancouver General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, FRCPC, Clinical Endocrinology Fellow, University of British Columbia', 'investigatorFullName': 'David E. Harris, MD', 'investigatorAffiliation': 'Vancouver General Hospital'}}}}