Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00768651
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2008-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Incretin Effect and Use After Clinical Islet Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peters@islet.ca', 'phone': '780-407-1480', 'title': 'Peter Senior, MD, PhD - Professor of Medicine, Medical Director-Clinical Islet Transplant Program,', 'organization': 'Faculty of Medicine and Dentistry, University of Alberta'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The major weaknesses of the study are the small sample size and the lack of a control group.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'One Arm: Sitagliptin + Pantoprazole', 'description': 'Intervention Details:\n\nSitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:\n\nPantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.\n\nSitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea or Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'One Arm: Sitagliptin + Pantoprazole', 'description': 'Intervention Details:\n\nSitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:\n\nPantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.\n\nSitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.56'}]}]}], 'analyses': [{'pValue': '< 0.05', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': "The sample size of 8 was determined to provide a 95% confidence interval expected width of 0.62 for the proportion of subjects who become insulin independent with treatment. Four of eight subjects (50%) would have to achieve insulin independence in order to reject the null hypothesis with 85% power and one sided alpha of 0.025. Statistical significance was set at 5%. Mean values were computed using Student's t-test while medians were compared using Wilcoxon's test.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Insulin independence was defined as no insulin use for at least one week, HbA1c \\< 6.0%, fasting plasma glucose \\< 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be \\>7.8 mmol/l (fasting) or \\> 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set of participants: The participants of subjects in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary variables.'}, {'type': 'SECONDARY', 'title': 'Insulin Independence After the 3 Month Washout Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'One Arm: Sitagliptin + Pantoprazole', 'description': 'Intervention Details:\n\nSitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.\n\nPantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.\n\nSitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After the 3 month washout period', 'description': 'Insulin independence was defined as no insulin use for at least one week, HbA1c \\< 6.0%, fasting plasma glucose \\< 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be \\>7.8 mmol/l (fasting) or \\> 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).', 'unitOfMeasure': '% of insulin indipendent participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set of participants; The subset of participants in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary and secondary variables.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose (U/Day)', 'timeFrame': 'After the 3 month washout period', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Daily Insulin Use (U/Day) After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline of GLP-1 Level After One Month of Therapy', 'timeFrame': 'Baseline and One month', 'description': 'Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline on Gastrin Level After One Month of Therapy', 'timeFrame': 'Baseline and One month', 'description': 'Gastrin levels were measured at baseline and at one month by method (manufacturer).', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Acute Insulin Responses to Arginine After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'An intravenous arginine stimulation test (AST) \\[Ryan:2002cg\\] was performed at baseline, 6, and 9 months to assess Graft function.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) \\[Ryan:2005ts\\] at baseline, 6 and 9 months to assess Graft function.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) \\[Ryan:2005ts\\] at baseline, 6 and 9 months to assess Graft function.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.', 'timeFrame': '6 months', 'description': 'Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) \\[Ryan: 2005ts\\] at baseline, 6 and 9 months to assess Graft function.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Weight Change From Baseline After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'Measuring the weight change from baseline at months: 1, 3, 6 and 9.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Insulin Response to Arginine After the 3 Month Washout Period', 'timeFrame': '3 months - washout period', 'description': 'An intravenous Arginine stimulation test (AST) \\[Ryan:2002cg\\] was performed at baseline, 6, and 9 months to assess Graft function. The Arginine is a proxy for insulin secretory reserve (Robertson:2004br)(Rickels:2007cg) and correlates with islet mass in the context of islet allo-transplant (Ryan:2002cg), auto-transplant (Teuscher:1998eu) and hemipancreatectomy (Seaquist:1992iv). An increase in Arginine (AIRarg) would have suggested an increase in beta cell mass.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period', 'timeFrame': 'After the 3 month washout period', 'description': 'Measuring of HbA1c using method (manufacturer) at baseline, and months: 1, 3, 6, 9.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.', 'timeFrame': 'After the 3 month washout period', 'description': 'Measuring of C-peptide before and 90 minutes after a Mixed Meal Tolerance Test (MMTT) \\[Ryan:2005ts\\] at baseline, 6 and 9 months to assess Graft function. Ther', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.', 'timeFrame': '3 months - washout period', 'description': 'Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) \\[Ryan:2005ts\\] at baseline, 6 and 9 months to assess Graft function.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.', 'timeFrame': '3 months - washout period', 'description': 'Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) \\[Ryan: 2005ts\\] at baseline, 6 and 9 months to assess Graft function.', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period', 'timeFrame': 'After the 3 month washout period', 'description': 'Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) \\[Ryan: 2005ts\\] at baseline, 6 and 9 months to assess Graft function.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin + Pantoprazole', 'description': 'Intervention Details:\n\nPantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months, followed by a three-month washout.\n\nSitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months, followed by a three-month washout.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment period took place between March 2010 thru October 2010. Consent took place in the Clinical Islet Transplant Program at the University of Alberta.', 'preAssignmentDetails': "Patients signed Informed Consent after a consultation with the PI. Then they proceeded through the evaluation phase of the study. During this phase, some patients were excluded based on the protocol's inclusion and exclusion criteria (i.e. lab reports or procedure that did not meet protocol standards)."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'One Arm: Sitagliptin + Pantoprazole', 'description': 'Intervention Details:\n\nSitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout:\n\nPantoprazole: Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.\n\nSitagliptin: Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '3.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes Duration Prior to 1st Transplant', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'groupId': 'BG000', 'lowerLimit': '24.7', 'upperLimit': '50.2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of islet infusions', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'number of islet infusions', 'dispersionType': 'FULL_RANGE'}, {'title': 'Islet equivalents infused', 'classes': [{'categories': [{'measurements': [{'value': '814,061', 'spread': '231,463', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'equivalents total', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Islet equivalents infused', 'classes': [{'categories': [{'measurements': [{'value': '12,046', 'spread': '4,030', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'equivalents per kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since first transplant', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '137'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Interval since last transplant', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '136'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time insulin free', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'groupId': 'BG000', 'lowerLimit': '15.4', 'upperLimit': '135.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Tacrolimus daily dose', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '1.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mycophenolate daily dose', 'classes': [{'categories': [{'measurements': [{'value': '1406', 'spread': '461', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients with evidence of early graft insufficiency following a period of insulin independence after one or more islet infusions for c-peptide negative type 1 diabetes participated in the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2008-10-07', 'resultsFirstSubmitDate': '2015-05-10', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-29', 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.', 'timeFrame': '6 months', 'description': 'Insulin independence was defined as no insulin use for at least one week, HbA1c \\< 6.0%, fasting plasma glucose \\< 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be \\>7.8 mmol/l (fasting) or \\> 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).'}, {'measure': 'Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy', 'timeFrame': '6 months'}, {'measure': 'Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.'}, {'measure': 'Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy', 'timeFrame': '6 months'}, {'measure': 'Mean Daily Insulin Use (U/Day) After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.'}, {'measure': 'Change From Baseline of GLP-1 Level After One Month of Therapy', 'timeFrame': 'Baseline and One month', 'description': 'Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.'}, {'measure': 'Change From Baseline on Gastrin Level After One Month of Therapy', 'timeFrame': 'Baseline and One month', 'description': 'Gastrin levels were measured at baseline and at one month by method (manufacturer).'}, {'measure': 'HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.'}, {'measure': 'Acute Insulin Responses to Arginine After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'An intravenous arginine stimulation test (AST) \\[Ryan:2002cg\\] was performed at baseline, 6, and 9 months to assess Graft function.'}, {'measure': 'C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) \\[Ryan:2005ts\\] at baseline, 6 and 9 months to assess Graft function.'}, {'measure': 'C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) \\[Ryan:2005ts\\] at baseline, 6 and 9 months to assess Graft function.'}, {'measure': 'Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.', 'timeFrame': '6 months', 'description': 'Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) \\[Ryan: 2005ts\\] at baseline, 6 and 9 months to assess Graft function.'}, {'measure': 'Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy', 'timeFrame': '6 months'}, {'measure': 'Weight Change From Baseline After 6 Months of Therapy', 'timeFrame': '6 months', 'description': 'Measuring the weight change from baseline at months: 1, 3, 6 and 9.'}], 'secondaryOutcomes': [{'measure': 'Insulin Independence After the 3 Month Washout Period', 'timeFrame': 'After the 3 month washout period', 'description': 'Insulin independence was defined as no insulin use for at least one week, HbA1c \\< 6.0%, fasting plasma glucose \\< 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be \\>7.8 mmol/l (fasting) or \\> 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).'}, {'measure': 'Insulin Dose (U/Day)', 'timeFrame': 'After the 3 month washout period'}, {'measure': 'Acute Insulin Response to Arginine After the 3 Month Washout Period', 'timeFrame': '3 months - washout period', 'description': 'An intravenous Arginine stimulation test (AST) \\[Ryan:2002cg\\] was performed at baseline, 6, and 9 months to assess Graft function. The Arginine is a proxy for insulin secretory reserve (Robertson:2004br)(Rickels:2007cg) and correlates with islet mass in the context of islet allo-transplant (Ryan:2002cg), auto-transplant (Teuscher:1998eu) and hemipancreatectomy (Seaquist:1992iv). An increase in Arginine (AIRarg) would have suggested an increase in beta cell mass.'}, {'measure': 'HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period', 'timeFrame': 'After the 3 month washout period', 'description': 'Measuring of HbA1c using method (manufacturer) at baseline, and months: 1, 3, 6, 9.'}, {'measure': 'C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.', 'timeFrame': 'After the 3 month washout period', 'description': 'Measuring of C-peptide before and 90 minutes after a Mixed Meal Tolerance Test (MMTT) \\[Ryan:2005ts\\] at baseline, 6 and 9 months to assess Graft function. Ther'}, {'measure': 'C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.', 'timeFrame': '3 months - washout period', 'description': 'Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) \\[Ryan:2005ts\\] at baseline, 6 and 9 months to assess Graft function.'}, {'measure': 'Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.', 'timeFrame': '3 months - washout period', 'description': 'Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) \\[Ryan: 2005ts\\] at baseline, 6 and 9 months to assess Graft function.'}, {'measure': 'Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period', 'timeFrame': 'After the 3 month washout period', 'description': 'Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) \\[Ryan: 2005ts\\] at baseline, 6 and 9 months to assess Graft function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27087519', 'type': 'DERIVED', 'citation': 'Senior PA, Koh A, Yau J, Imes S, Dinyari P, Malcolm AJ, Light P, Shapiro AM. Sitagliptin plus pantoprazole can restore but not maintain insulin independence after clinical islet transplantation: results of a pilot study. Diabet Med. 2017 Feb;34(2):204-212. doi: 10.1111/dme.13131. Epub 2016 May 22.'}]}, 'descriptionModule': {'briefSummary': 'We aim to study if the administration of medications to increase the secretion of hormones from the intestines can improve glycemic control, reduce insulin use and promote β-cell regeneration/expansion in subjects with type 1 diabetes following islet transplantation who are back using small doses of insulin because of early graft dysfunction. We believe that the results will enable us to understand whether these drugs could be useful in islet transplant recipients, particularly if glycemic control deteriorates.', 'detailedDescription': 'This is a single centre non-randomized pilot study. Subjects will be recruited from the current cohort of islet transplant recipients at the University of Alberta.\n\nThe primary objective of the study is to evaluate whether the combination of sitagliptin and pantoprazole can restore insulin independence in previously insulin independent islet transplant recipients experiencing early graft dysfunction. The study will also evaluate the safety of the combination drug therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nSubjects must meet the following criteria to be enrolled in this study:\n\n1. Male or female, aged 18 to 70, inclusive, who is a previous islet transplant recipient (at least 3 months since last islet transplant) and who received their transplant at the University of Alberta.\n2. Insulin independent for 3 months or longer after islet transplant.\n3. Early graft dysfunction as defined by:\n\n 1. HbA1c \\>6% (but less than 7.5%); or\n 2. fasting glucose \\> 7 mmol/L (126 mg/dl); or\n 3. random glucose \\> 10 mmol/L (180 mg/dl), and\n 4. Total insulin use of \\< 10 units/day.\n4. C-peptide positive.\n5. Able to provide informed consent.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from the study:\n\n1. Unable to provide informed consent.\n2. Prior therapy with sitagliptin or a proton pump inhibitor in the preceding 2 months.\n3. Vulnerable populations (i.e. cognitively impaired, pregnant women, residing in institutions, University of Alberta students or employees under the supervision of any of the investigators).\n4. Children, adolescent or patients with a "contraindication" or "warning" listed in the package insert of any of the study drugs:\n\n 1. Hypersensitivity to sitagliptin or pantoprazole for any component of the formulation.\n 2. Renal disease or renal dysfunction (as suggested by serum creatinine levels ≥ 136 µmol/L (males), ≥ 124 µmol/L (females) or abnormal creatinine clearance; or estimated by Glomerular Filtration Rate (GFR) \\<50 ml/min/1.73m2).\n 3. Acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).\n5. Uncontrolled hyperglycemia\n6. Any subject that in the opinion of the investigator would not be a good candidate for study participation.'}, 'identificationModule': {'nctId': 'NCT00768651', 'briefTitle': 'Incretin Effect and Use After Clinical Islet Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Pilot Study of Safety and Efficacy of Combined Use of Dipeptidyl-peptidase Inhibitor (Sitagliptin) and Proton Pump Inhibitor (Pantoprazole) to Prevent Beta-cell Apoptosis and Promote Islet Regeneration in Islet Transplant Recipients With Early Graft Dysfunction', 'orgStudyIdInfo': {'id': '7331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One arm: Sitagliptin + Pantoprazole', 'description': 'Intervention Details:\n\nSitagliptin 100 mg daily and Pantoprazole 40 mg bid for 6 months, followed by a three-month washout.', 'interventionNames': ['Drug: Pantoprazole', 'Drug: Sitagliptin']}], 'interventions': [{'name': 'Pantoprazole', 'type': 'DRUG', 'otherNames': ['Pantoloc'], 'description': 'Starting on Day 1, Pantoprazole 80 mg daily (40 mg every morning and 40 mg every evening) administered orally at the same time each day for a period of 6 months.', 'armGroupLabels': ['One arm: Sitagliptin + Pantoprazole']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'Starting on Day 1, Sitagliptin 100mg once daily administered orally at the same time each day for a period of 6 months.', 'armGroupLabels': ['One arm: Sitagliptin + Pantoprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G2C8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta - Clinical Islet Transplant Program', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Peter Senior, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}